Senior Supplier Quality Engineer Resume Samples

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J Kihn

Jared

Kihn

6450 Zemlak Village

Los Angeles

+1 (555) 863 5466

6450 Zemlak Village

Los Angeles

Phone

p +1 (555) 863 5466

Experience Experience

San Francisco, CA

Senior Supplier Quality Engineer

San Francisco, CA

Corwin Inc

San Francisco, CA

Senior Supplier Quality Engineer

Develops risk management plans, reports, and utilizes risk management tools such as FMEAs
Leads activities related to supplier development including process development, scrap reduction, sub-supplier management
Develop and improve the Supplier Quality Management including ECOs, NCRs, SPC (statistical process control)
Planning and allocating Supplier Development, Manufacturing Engineering and Supplier Quality Engineer to work tactical and strategic improvements
Manages the early involvement of suppliers in new product development and product/component improvement. Leads quality system audits
Continually assess the Supplier Management and QA Management system and SOP’s for continual improvement
Working on improvement actions in support of supply chain Quality and Delivery performance

Phoenix, AZ

Senior Supplier Quality Engineer B-chassis

Phoenix, AZ

Bode, Kuhic and Jaskolski

Phoenix, AZ

Senior Supplier Quality Engineer B-chassis

Present program status to Management and Executive Leadership both within and outside of Supplier Quality
Participation in launch teams for purchased components within the vehicle platforms
Be an effective liaison between the supplier and the extended FCA team
Proficient in using Microsoft Office Suite software
Assist in the development of Supplier Quality programs and processes designed to improve supplier performance and productivity
Assists in developing & executing: global annual strategic targets, improvement initiatives, policies, procedures and vision
Leads activities within the Interiors Supply Chain Management functions to improve supplier quality, delivery, and performance for the assigned commodity areas

present

Dallas, TX

Senior Supplier Quality Engineer C-powertrain

Dallas, TX

Schinner, Hilpert and Williamson

present

Dallas, TX

Senior Supplier Quality Engineer C-powertrain

present

Perform supplier quality systems and process audits and lead Supplier Improvement/Development Programs
Establish close relationships with assigned suppliers and actively drive continuous improvement activities
Establish close relationships with assigned suppliers and actively drive continuous improvement activities following the FCA Foundational Principles
Work with Engineering and Supplier Organizations to alleviate discrepancies in product specifications and evaluate cost reduction opportunities
Initiate and follow-up on corrective actions and verify effectiveness on-site
Audit supplier's quality systems and manufacturing processes, including critical production processes at sub-tiers
Participation in launch teams for purchased components within the vehicle and powertrain platforms

Education Education

Bachelor’s Degree in Engineering

University of California, Berkeley

Bachelor’s Degree in Engineering

Skills Skills

Robust technical knowledge with excellent communication skill, ability to develop a strong partnerships with the suppliers
Ability to execute Quality methods and systems (statistics, reliability, sampling, and auditing, problem solving)
Good learning capability / adaptability to new things
J. Working knowledge of prototype production and quality systems and ability to facilitate samples to internal and external customers
Very good capability of influencing people & strong personality
Good issue analysis capability, able to use data analysis, experiments to find out solution
Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills)
Knowledge on Aerospace Quality Systems (QS), Technical Standards (TS) and Advanced Product Quality Planning (APQP) standards and processes
Analytical – Strong statistics knowledge as it relates to new product development. Strong analytical skills. Critical thinking for investigational purposes
Good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.)

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15 Senior Supplier Quality Engineer resume templates

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Senior Supplier Quality Engineer Resume Examples & Samples

Supplier manufacturing quality – drive implementation of Pro-Cert / Quality improvements at key RCS suppliers
Work with developing suppliers to improve / implement robust quality systems prior to becoming RCS suppliers
Provide on-site guidance and coaching to key component and branded product suppliers to drive improvements in SPPM, OTD and warranty costs

Senior Supplier Quality Engineer Resume Examples & Samples

Conducts audits and assessments
Leads activities within the Interiors Supply Chain Management functions to improve supplier quality, delivery, and performance for the assigned commodity areas
Leads qualification activities associated with new parts and re-qualifies parts as they are transitioned to alternate suppliers
Trains and supports suppliers to prepare documents for component parts including process capability studies, measurement system analysis, control plans, etc
Coordinates and facilitates, as required, the supplier corrective actions to improve processes, quality, capability, etc. This includes process recommendations as well as surveillance as required
Leads supplier quality root-cause and corrective action analysis. Provides supplier assistance by establishing root-cause and creating a control plan
Leads activities related to supplier development including process development, scrap reduction, sub-supplier management
Acts as the expert on supplier quality tools and leads/assists with roll out, training and implementation of standardized supplier quality tools
Facilitates and trains external suppliers in Continuous Improvement methodology
Manages the flow-down process for UTAS, regulatory, and customer requirements
Coordinates Supplier performance requirements

Senior Supplier Quality Engineer Resume Examples & Samples

Supporting supplier sourcing teams in the evaluation and selection of global best-in-class third party suppliers
Communicating quality expectations to suppliers and partnering effectively with them to develop quality systems, processes and controls to fulfil these expectations
Engaging with suppliers to execute process qualification plans and reports to assure components and materials
Leading global supplier quality system audits, ensuring timely and appropriate action is taken
Assessment of supplier processes for optimum output, process stability and controls, identifying and implementing strategies for continual quality improvement and control
Development and certification of suppliers to achieve Dock to Stock status for supplied components
Monitoring, analysing and identifying trends from supplier quality and performance data
Review and disposition of supplier change requests, coordinating activities with suppliers and with internal crossfunctional support teams to develop and implement appropriate strategies to qualify and support the change
Review and evaluate changes to specifications for purchased components and materials, ensuring changes are consistent with quality objectives
Application of sound technical judgment, statistical analysis and quality tools to aid the resolution of complex problems
Develop technical solutions to complex problems using the corrective/preventative action process
Functioning effectively as part of cross functional and cross organizational teams, developing strong partnering relationships with Suppliers, Supply Chain, Design, Manufacturing and Quality groups
Represent the organization as the primary supplier technical contact on components, at times requiring coordination between organizations
A Level 8 NFQ Bachelor's degree in a relevant technical discipline (i.e.: Engineering, Materials, Science)
A minimum of 5 years working experience, preferably within the medical device or related industry
Previous supplier engineering experience is advantageous
Knowledge of applicable GMP, FDA and ISO regulations and of other appropriate guidance documents / standards
To have attained Certified Lead Auditor status would be an advantage
Practical working knowledge of statistical data analysis and quality improvement tools and techniques preferable

Senior Supplier Quality Engineer Resume Examples & Samples

Identify and plan training to address gaps in both skills and behaviour. Form input to performance reviews
Liaising with the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues
Track supplier quality performance measurement (KPI's) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review

Senior Supplier Quality Engineer Resume Examples & Samples

Lead activities within the Commodity Management Team (CMT) to improve supplier quality, delivery, and performance for the assigned commodity areas
Be an expert on Supplier Quality Tools – Lead / Assist with roll out, training and implementation of Supplier Quality tools for suppliers
Liaison effectively with Commodity Managers, other Supplier Quality Engineers, Program Managers, Quality Engineers, Production Engineers and suppliers to identify and fully satisfy requirements for quality engineering activities at North American factories
Will include travel – domestic and/or international up to 25%
Bachelor’s Degree in Electrical/Mechanical Engineering or related undergraduate degree required, Graduate degree preferred
Knowledge of PWBA, raw circuit boards, electronic components, and functional testing
Experience with EMS Suppliers
At least 3 years work experience as SQE and/or SDE, including the identification, selection, development and management of global suppliers
Bilingual – English and Spanish
Execution – persistent drive for results utilizing sound project management, organizational and problem solving skills

Senior Supplier Quality Engineer Resume Examples & Samples

Utilizes engineering background and expertise to communicate between global team members, customer counterparts and suppliers to provide assurance that the hardware is compliant to specifications. Handles and communicates deviations/non-conformances at different levels within the organization. Understands and communicates typical manufacturing processes (machining, welding, NDT, etc.) and how they are applied to the hardware being manufactured
Manages the quality/Technical activities between launch SQ teams on NPI programs, including ODT and PPAP assessment with approval of capability and capacity
Conducts collaborative quality system and process audits (eg VDA 6.3) at suppliers, and tracking open items through to 100% closure
Applies modern quality principles, concepts and methods, including Lean Manufacturing, Six Sigma, and process variation management tools to continuously improve processes, reduce cost and ensure the quality of our products and services
Interprets engineering drawings and specifications, customer quality requirements and company quality requirements to ensure compliance with the customer's expectations and Honeywell TS Quality requirements, QCI’s, PI’s and best practice
Drives corrective and preventative action activity both in-house and at the supplier, and provides corrective action board support to manage timely and effective problem closure and recurrence control. Experience with 8D. 5Why, cause/effect, and similar root cause analysis tools
Participates in design reviews (APQP) to identify inspectability and producibility issues and opportunities early in the product life cycle, in partnership with commercial and engineering teams
Provides a clear and concise flow down of product definition and Quality requirements to Suppliers
Prepares comprehensive analyses, procedures, reports and presentations for both internal and external customers. (COE, AE, PE, Plant SQA, CT etc) using fluent spoken and written English with a strong ability to lead
Experience with mechatronics, actuation, or electrical engineering is a plus

Senior Supplier Quality Engineer Resume Examples & Samples

Degree in Mechatronic/Electronic Engineering with specialization in E-Actuators/Electrification or equivalent
A minimum of 5 years work experience in E-Actuators/Sensors operations, preferably within the automotive business
Knowledge of suppliers in the automotive sector will be an added value
Production process experience in E-Actuators/Electrification, assembling and measuring
Six Sigma experience – Lean Expert or Black Belt is a plus
Knowledge in Product & Process Auditing, preferably based on VDA 6.3
Knowledge of Quality tools & practices such as AIAG - APQP, PPAP, D&PFMEA, DOE, ISO TS-16949

Senior Supplier Quality Engineer Resume Examples & Samples

BE Mech / Electrical with Min 5 Years Experience in MNC Company
Experience in Leading Supplier Developments
Handsome experience in Plastics & Sheet metal
Good communication & presentation Skill

Senior Supplier Quality Engineer Resume Examples & Samples

Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO)
Address and correct product and process complaints
Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
A Degree in Engineering, Life Science, or related discipline is preferred
Both, FDA and ISO regulations knowledge is required, FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
Auditing background is preferredQuality (Eng)

Senior Supplier Quality Engineer Resume Examples & Samples

Experience with manufacturing or assembly of mechanical products (inspection, design, machining, etc.) preferably as a manufacturing engineering, industrial engineer, or design engineer
Strong mechanical knowledge
Experience in the creation, or modification of software driven quality systems such as MPR system, SCAR system or a purge system; experience defining system architecture (how the product should work) and project managing the software changes
A self-starter and be strongly invested in defining problems and driving solutions to those problems in a cooperative and cross-functional environment
Work experience in multiple disciplines including operations areas such as manufacturing, project management, quality, materials, purchasing
Experience working with suppliers of fabricated products either as a customer interfacing with a supplier or as a supplier representative
Lean 6 sigma experience and a Green or Black Belt
Certified Quality Engineer (ASQA/E or equivalent) and significant experience in auditing suppliers
Demonstrated ability to read drawings, preferably an understanding of GD&T and make reasoned judgments on the “quality of the designs”
Demonstrated ability to identify product and process risks; identify solutions and drive those solutions
Demonstrated ability to identify cross functional problems and possess the knowledge of other functional areas, then recommend and drive solutions to these problems
Understanding of how to collect and employ metrics to drive continuous improvement of suppliers quality (DPPM / MPR / SCAR)
Demonstrated ability to manage a product safety issue to conclusion
Responsible for driving DPPM (Defected Parts per Million) on a targeted downward trend for their assigned commodities by identification of problems and concerted work with key suppliers
Issue and review SCARs (Supplier Corrective Action Requests) for their assigned suppliers and work with suppliers to verify Root Cause Analysis (RCA) and Permanent Corrective Actions (PCA) implemented by the suppliers
Draft procedures or new processes and manages them through the approval process to completion with little supervision
Implement quality improvements, process mapping, process validations, software validations, production efficiency improvements, and process controls based on trend analysis

Senior Supplier Quality Engineer Resume Examples & Samples

Plans and conducts scheduled assessments of suppliers to assess compliance with Boston Scientific requirements. Includes assessment preparation meetings and scheduling in advance of site visit. Conducts and confirms follow-up actions on Supplier Quality System Assessments
Assesses supplier capabilities through direct visits, technical discussions and Quality System Assessments
Prepares detailed trip reports and Assessment Reports to document assessment findings and observations
Interfaces with the Procurement Commodity Specialists
Maintains accuracy of SAP Vendor Assessment Report and Supplier Profile Reports
Provides guidance to Purchasing and Engineers in applying supplier quality system requirements
Trains suppliers, assessors, and other BSC personnel on QA specifications for suppliers
Support the day to day activities that take place for activities related to Alliance partner products
Has the responsibility authority to make decisions related to incoming components, including the disposition of non-conforming product
Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within supplier controls and incoming inspection constantly promoting awareness of best industry practices and making appropriate decisions .
A Bachelor (HETAC level 8) of Engineering, Sciences or equivalent experience with a minimum of 8 years experience in a relevant environment
A thorough working knowledge of Risk Management and Validation techniques
Experienced in the application of Six Sigma techniques
People management experience essential

Senior Supplier Quality Engineer Resume Examples & Samples

Management of suppliers by commodity to positively impact PPM metrics
Conducts Q+ System Audits and Process Qualification Audits
Integral team member of the supplier qualification process
Investigates and resolves reported supplier-related manufacturing issues
8Ds, APQP activities, defect resolution, reduces/eliminates warranty issues
Corrective Action Team project support
Addresses field complaints
Conducts monthly reporting duties for Carrier Corporate and UTC WHQ

Senior Supplier Quality Engineer Resume Examples & Samples

Participate and co-author Subcontract Management Plans
Ensure strategic suppliers develop and maintain an active Risk Management Plan
Ensure organization has effective root cause problem solving activities and successful identification of systemic issues and corrective action
Participate as needed in the selection, evaluation, flow down quality requirements, monitoring and supplier development activities as a primary team member
Participate in securing supplier responses to corrective action requests to meet planned due date
Interfaces with Customer on supplier issues, as required. Present information to management on supplier status
Typically requires a bachelor's or master's degree in engineering or related discipline and ten or more years of related experience with a bachelor's degree or eight or more years with a master's degree. May substitute equivalent experience in lieu of education
Must possess the technical skills required to oversee innovative designs and to solve complex technical problems
Must have advanced computer skills with versatile knowledge of computer operations pertinent to the field
Able to work extended hours as required
The ability to read and interpret complex engineering drawings and specifications is a desirable
Manufacturing and/or quality background in electrical components, PWB, PWA, J-Stds, electromechanical assemblies, avionics, SATCOM and cable assemblies is desirable

Senior Supplier Quality Engineer Resume Examples & Samples

Assists in developing & executing: global annual strategic targets, improvement initiatives, policies, procedures and vision
Establish annual global audit plan for suppliers and maintain oversight. Create strategies for SQE audit criteria and audit protocol. Track & monitor supplier audit related issues for input into categories, supplier selection and enterprise risk management
Global oversight of the Supplier Quality Improvement Plan process (SQIP)
Accumulate & provide input in the supplier selection process from an SQE perspective
Monthly reporting & review against SQE KPI’s and targets
Visit Harman facilities and meet with SQA personnel to ensure a full understanding of Customer (internal & external) needs / requirements to identify process and improvement opportunities
Manages the global QBR calendar for SQE preparation and participation
Develops and maintains SQE systems, processes & tools and provides global training (e.g., PPAP, APQP, Run @ Rate, Safe Launch)
Minimum 5+ years related experience required
Must have a thorough working knowledge of principles and procedures related to Supplier Quality Engineering, statistical applications, problem solving methology (8D), automotive production part approval process (PPAP), auditing to VDA 6.3 / TS16949 requirements, and Quality Operating Systems
Expert skills in word processing, spreadsheet and presentation preparation (MS OfficeSuite)
Good working profiency in ERP systems (SAP preferred)
Bachelor’s degree in an engineering discipline
Global, multi-location support / oversight experience
ISO / VDA auditor certification

Senior Supplier Quality Engineer Resume Examples & Samples

Supervises both exempt and non-exempt staff supporting component qualification and MRR
Participates in Supplier audits to ensure compliance to Quality System Regulation (QSR) 21CFR 820, ISO13485:2003, Medical Device Directive (MDD) 93/42/EEC, and Glens Falls and Corporate policies/procedures
Works closely with Purchasing and CIP functions to support the qualification of Suppliers for existing and new materials/components
Identifies and implements continuous improvement projects in IQC including: reduced sampling and efficient inspection/test methods
Participates in the IQC MRR and SCAR programs to assure timely investigations, root cause analysis, corrective action, closure, and effectiveness. Assist in trending/analyzing IQC and Supplier Quality metrics (MRRs, SCARs, inspection turn-time)
Participates in development of the Quality Strategy to drive improved quality facility-wide
Evaluates manufacturing quality, yield issues, customer complaints and drives corrective action
Uses failure investigation tools to investigate causes of customer, manufacturing, and Supplier Quality issues. Takes the lead with other functional groups in resolving those issues
Serves as quality representative on Material Review Board. Takes the lead in driving corrective action from MRB
Interfaces with other functional areas as required for writing specifications, preparing protocols and reports, implementing changes, completing process validation requirements, etc
Develops appropriate test and inspection procedures and sample plans to ensure the highest possible quality at a reasonable cost. Develops and modifies test methods and appropriate inspection procedures and protocols
Demonstrated experience in supplier relation, auditing, supplier corrective action and supplier / component qualification
ASQ Quality Engineer certification is desirable
Minimum of B.S. year degree in engineering, scientific or technical discipline
Minimum 10 years related experience with demonstrated expertise in quality concepts, philosophies, and methods
Minimum 7 years experience in a quality engineering role, in the medical device or other regulated industry
Minimum of 3 years supervisory experience at a professional level

Senior Supplier Quality Engineer Resume Examples & Samples

Participate on teams, being the primary quality point of contact, working with suppliers primarily in the US and partially on the Asian sub-continent. Traveling is approximately 20%
Measures suppliers’ performance through data analysis and trending
Conducts on site audits (21 CFR Part 20, ISO 13485 and ISO 9001) and supplier performance evaluation required based on company procedures. Will ensure compliance with the supplier performance management system. Manage CAPA for QMS non-conformances identified
Conducts trend analysis, identify system issues, summarize findings and prepare reports for key quality and product metrics
Responsibilities also include being the supplier QE representative in technical teams, initiating SCARs for non-conformances, setting priorities for corrective action efforts, and working with the team on component related failure investigations
Responsible for supporting Development/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive action
Drive continuous improvement efforts, through facilitating, and collaborating with cross function teams including BD and Suppliers
Responsible for reporting of quality trends and information to management on the performance of sourcing-related quality systems
Develop positive relationships and work closely with Global Sourcing Leaders and Procurement/Supply Chain to manage and implement supplier/engineering changes, New Product Introductions, and transfers
Demonstrated ability to acknowledge, develop, communicate & implement a strategy to ensure compliance
Work with supplier to establish a structured approach for consistency and adherence to quality procedures and requirements
Follow up non-conforming from the supplier audit, during-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify / drive root cause analysis, corrective action and preventive action implementation
Work Closely with US QA team to manage suppliers to ensure the product quality
Bachelor's degree in technical field and 4-5 years’ experience is required; or equivalent combination of education and experience
Experience with managing supplier quality in the production of PCBs/PCBAs, and electronic assemblies
Direct experience with supplier producing parts in a regulated environment (Medical Device, Automotive, Aerospace) preferred
Must have knowledge of Quality Engineering discipline, including statistics
Strong working knowledge of DMAIC \Six Sigma problem solving process. Belt certified a plus
Competent in Auditing, CAPA, Equipment Qualification
Candidate must have high energy and lots of stamina. Must be a team player, and have a strong work ethic. Must have good communication skills
ASQ Quality Audit Certification a plus

Senior Supplier Quality Engineer Resume Examples & Samples

BS/BA degree in Engineering or Science
4+ year quality or manufacturing experience
2+ year experience in medical devices or other regulated industry
Understanding of Supplier Quality Management
Computer Skills (Microsoft Word, Excel, Project, PowerPoint)
Use and understanding of Statistical Tools
Good Oral and Written communication skills
Ability to work in a collaborative and cross-functional (Matrix) team environment
Six Sigma and Lean Experience

Senior Supplier Quality Engineer Resume Examples & Samples

Ensure the Approved Supplier List is maintained and is accurate
Administer supplier surveys, and assess supplier quality system and process control capabilities
Maintain supplier audit schedule and conduct audits of new and existing suppliers to assess manufacturing capability and adherence to accepted quality practices
Lead efforts in identifying, communicating, and resolving supplier quality problems. Develop and monitor supplier corrective and preventative action plans and activities as necessary
Administer the Supplier Corrective Action Request (SCAR) process
Act as supplier quality representative on the material review board (MRB). Investigate causes of quality and yield issues. Interface with other functional groups in resolving those issues
Ensure implementation of quality system procedures and compliance to FDA QSR and ISO 13485:2003 requirements as they relate to supplier quality
Provide supplier quality input to the R&D group
Capably perform all supplier quality tasks required by Solta procedures
Additional duties as defined by supervisor
Bachelors of Science in Engineering or other related technical field
A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision
Must have excellent work ethic, personal responsibility, initiative, and teamwork skills
Strong knowledge of medical device supplier quality requirements
Strong knowledge of FDA QSR and ISO 13485:2003 supplier quality requirements
Minimum of 5 years’ experience in manufacturing/quality engineering, with a minimum of 3 years in supplier quality
Familiarity with inspection/test development and process validation
Understanding of electro-mechanical software-controlled systems and associated manufacturing processes
Effective verbal and written communication, analytical and interpersonal skills
ASQ or other certification (CQE) in SQE and/or auditing a plus
Agile experience a plus
Proficient in the use of PC software (MS Word, Excel, etc.)

Senior Supplier Quality Engineer Resume Examples & Samples

Support and execute effectively projects responsibilities across SGS
Ensure effective completion of project deliverables by execution of applicable business processes relating to project activities
Provide regular and timely project status updates inclusive of key achievements, next significant milestones/gates, and barriers and slippages to key stakeholders
Lead and/or support structured reviews and updates for supplier quality projects & Programs. Set clear expectations from a supplier quality perspective for suppliers
Accurately define timelines and resource requirements for assigned projects by the use of best practice project management tools in order to seek adequate support

Senior Supplier Quality Engineer, Projects Resume Examples & Samples

Leverage greater efficiencies in the group by applying standardised/harmonised methodologies to the supplier quality project activity management and tactical execution in each site
Influence across the organisation by building effective relationships with all relevant key stakeholders as well as fostering trust and collaboration with Global Supplier Quality functions, Global Quality, Strategic Sourcing
Ensure the use of proven best practices and act as SME to train others in the SQ organization on quality requirement changes adopted by quality improvement programs both internally and externally
As a project SME conduct and support quality benchmarking activities at suppliers to identify areas of continuous improvement opportunities
Support project budgets in association with key stakeholders. Analysing project variance and recommending appropriate actions
Develop or support the development of KPIs and tracking methodologies with program managers
Support program managers in the development and co-ordination of clearly defined “get well” plans when and where required during the course of the project
Assume overall responsibility for deliverables and drive adherence to overall project deadlines and milestones
All other duties as assigned per performance goals and objectives as well as leadership expectations

Senior Supplier Quality Engineer Compliance Resume Examples & Samples

Ownership and reporting on all quality issues associated with suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated
Oversight of the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non conforming products
Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
Develop structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier
Oversight of the Approved Supplier List (ASL) in conjunction with the Procurement function

Senior Supplier Quality Engineer Resume Examples & Samples

Overall supplier performance (RDSL, PPM) management and analysis
By product family
By Commodity
New and potential suppliers’ audits to understand and assess their quality system to determine if it meets Emerson requirements. Develop corrective actions or development plans to supplier to meet our objectives. Drive continuous improvements until objectives are met
Proactively provide comparisons and comments on supplier’s quality controls, manufacturing capability and capacity
Coordinate pre Technical and Technical Review and attend design reviews with suppliers, to confirm the drawings, specifications, method of measurement and PPAP requirement
Conduct FA & Pilot Run follow with suppliers in cooperation with Commodity Teams and Quality teams for all projects which could be NPD, regionalization, localization, supplier shifts for Risk Mitigation or cost savings or replacements of tooling
Conduct and manage supplier quality performance during production such as
Day-to-day quality issue improvement and SCAR following up
Monthly performance report, including PPM, RDSL
Periodical supplier visits and process audit based on annual SBR plan
Work for supplier continuous improvement project as project leader or coach
Conduct supplier’s trainings if necessary to improve supplier’s performance
Performs related work as apparent or assigned by direct manager
Good communication and project management skill
Assertive, aggressive and confident
Good command of English (written/oral) and PC
Willing to travel frequently to visit and audit suppliers

Senior Supplier Quality Engineer C-irf Resume Examples & Samples

Educating plant staff on FCA Supplier Quality systems and requirements
Manage the production part approval process (PPAP) for running changes as needed on current production programs
Bachelor of Science degree in Mechanical Engineering or Electrical Engineering from an ABET accredited university with a minimum 3.0 GPA. A bachelor's degree in
Comfortable with complex technical analysis

Senior Supplier Quality Engineer Resume Examples & Samples

Verification, trending, and reporting of supplier quality data to both RPM and customers as require
Leading or assisting process audit teams (Pre-Work Authorization Reviews, Post-Award Reviews, Product/Process Verification) at suppliers and ensuring that compliance is demonstrated through objective evidence Ensuring suppliers understand all technical and contractual requirements
Guiding suppliers through PFMEAs and other error proofing/preventive action activities
Requesting root cause and corrective action from suppliers when warranted and performing verification and validation of any changes resulting from the corrective action
Generation, review and/or approval of supplier risk mitigation plans, source inspection plans, and supplier inspection plans
Review and approval of supplier First Article Inspections (FAIs)
Ensuring suppliers implement SPC as required and performing review and approval of SPC data for lot acceptance
Performing source inspection at suppliers as required
Ensuring suitable containment and identification of supplied non-conforming material
Dispositioning supplied non-conforming material and obtaining customer concurrence where required
Ensuring contractual quality requirements are fulfilled
Minimum four (4) years Supplier Quality Engineering experience
Significant experience in the following domains
O Casting and forging processes, procedures and equipment
Six (6) years or more of Supplier Quality Engineering experience related to casting, forging, or machining processes
ASQ CQE or CQA
Mission Assurance Certification Program Level 5 (internal candidates only)
Experience in creation or modification of CNC and/or CMM programmable logic
Familiarity with Model Based Designs
Experience using RCAS and SHARP tools
Able to obtain a DoD Secret clearance

Senior Supplier Quality Engineer Resume Examples & Samples

Five (5+) Years experience in a manufacturing environment
Minimum of 4 years Quality/Manufacturing Engineering Experience
Minimum of 5 years’ experience in a Supplier Quality capacity highly desirable
Understanding of ISO 9001 and other regulatory standards
Prior Supplier Quality experience in manufacturing and an analytical approach to problem solving
Must be a critical thinker and active listener with good time management skills in order to work with Suppliers and Project Management teams to define deliverables
Strong project management skills. PMP ideal

Senior Supplier Quality Engineer Resume Examples & Samples

Designs, develops, and implements comprehensive supplier quality programs
Responsible for supporting supplier facility surveys of existing and potential critical components providers
Reviews and evaluates processes and services to correct Quality System and supplier deficiencies and to subsequently formulate improvements
Works to ensure product quality, performance, and conformity with applicable regulations and company established specifications
Recommends changes or other action as appropriate (supplier consolidation, quality improvement and cost reduction opportunity, etc)
Analyzes and reviews product changes to ensure conformity with applicable regulations and company established specifications
May be involved with outside Inspection of the Quality System: FDA and Notified Body auditors
Performs other duties as assigned by manager
Masters or Bachelors in Electrical, Mechanical, Industrial, or Biomedical Engineering
2-6 yrs. Industry Experience
Knowledge of Six Sigma tools & methodologies, with proven ability to apply them
Knowledge of Quality Management System Tools, Continuous Improvement Methodologies & In-Depth Understanding of Site Level Products & Related Processes

Senior Supplier Quality Engineer Resume Examples & Samples

5 years’ work experience in supplier/manufacturing engineering and supply chain area
Experience with Geometric Dimensioning and Tolerancing (GD&T), time analysis, statistical process control, Measurement System Analysis (MSA), Failure Modes and Effects Analysis (FMEA), Gage Repeatability & Reproducibility (Gage R&R), capability analysis (Cp, Cpk), etc
Experience with aluminum die casting and machining, metallurgy, iron and steel machining processes
Working experience with ISO standards
Knowledge on Aerospace Quality Systems (QS), Technical Standards (TS) and Advanced Product Quality Planning (APQP) standards and processes

Senior Supplier Quality Engineer Resume Examples & Samples

Position focuses on an experienced individual in the Quality Engineering function related to manufacturing processes, specifically in Supplier Quality field working with multiple suppliers and different commodities as well as directly supporting a manufacturing plant environment
Must be a critical thinker and active listener with good time management skills in order to work with suppliers and project management teams to define deliverables; also adept at identifying and solving problems and possess solid communication and managerial skills
Must have knowledge of a company's manufacturing process, applications and process development in order to actively work with suppliers in improving quality components of goods and services. Quality audits must be performed on suppliers to assure products and services meet International Organization for Standards (ISO), regulatory standards and Company Policies
Responsible for investigating, analyzing and correcting problems in quality, production and control at a supplier location, also implement new strategies established by Supplier Quality Management
Will directly get involved with functional objectives and goals and personally contribute to those goals and track performance with metrics
Forms good relationships with members of supply chain and the supplier system in order to maintain a strong support system and supplier relationships for the organization
7-10 years of related experience
Fluent in English language (spoken, written, understanding)
Strong interpersonal and communication skills with ability to communicate up to all levels of an organization
Strong Presentation skills and statistical analysis experience with ability to crunch data and be able to get to a solution and improve processes
Nonconformance management with root cause problem solving – CAPA
Knowledge of traditional process and layer audit tools
PPAP and basic Automotive tools
Process capability studies and improvement tools
Process control and manufacturing techniques
Six Sigma and Lean Six Sigma tools
Black Belt Certification
Various lead times in purchasing and production
Computer and software expertise

Senior Supplier Quality Engineer Resume Examples & Samples

Generates and maintains incoming inspection procedures. Trains inspectors to these procedures
3Develops and/or sources inspection tools and equipment
Assists in generating component specifications
Generates test protocols, monitor testing, issue qualification test reports and approve components for use in products
Provides input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis
Analyzes incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers
Reviews new design specifications and provides input from component quality and manufacturability perspective
Investigates field failures related to supplier materials. Develop corrective action plan where necessary
May supervise inspectors
Lead Auditor Certification A+
1345/CFR experience A+
Supplier Audit experience A+
Manufacturing experience A+
Medical Device/Pharma experience preferred
Travel up to 30%

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelor’s Degree in mechanical engineering, biomedical engineering (or other applicable technical degree) or related discipline and a minimum of eight to twelve (8 to 12) years related experience OR
Master’s degree in mechanical engineering, biomedical engineering (or other applicable technical degree) or related discipline and a minimum of six to eight (6 to 8) years related experience
Strong background and experience in plastic injection molding and tool development and qualification
Ability to work effectively in a team environment and build strong working relationships
Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills)
High degree of initiative and self motivation
Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485
A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, etc
Certified in Lean manufacturing and/or Six Sigma green belt
Experience in product mechanical evaluation & testing and GD&T

Senior Supplier Quality Engineer Resume Examples & Samples

Review assigned projects and provide cost effective designs and processes with suppliers based on compliance with established company standards and customer specifications including EBS, EQS, ELSS, MESH and ProLaunch
Lead projects to resolve systematic issues that will improve supplier quality and increase customer satisfaction, and developing robust manufacturing and business processes as needed with suppliers. Drive continuous improvement
Interact with other department members to solve problems and to ensure company goals and deadlines are achieved
Evaluate supplier performance concerns through root cause techniques to facilitate improved efficiencies and productivity
Work with suppliers on 8D Supplier Corrective Action Requests to ensure permanent and preventive actions
Conduct Supplier Quality Assessments for new and existing suppliers to drive minimum requirements and expectations for giving new business or sustaining business with Eaton
Manage project risks including resource constraints, meeting timelines and milestones, technical design and process risks
Establish, evaluate and monitor timelines in order to meet expectations of customer and the company for time, cost and quality
Establish communication link between stakeholders, customers, project team and production in order to meet production demands for launch. Support teams in the quest for excellence utilizing process improvement techniques (i.e. VA/VE, Kaizen, DOE, QFD, VSM, APQP, etc.)
Work with suppliers on sample parts approval
Ensure consistency/standardization of how the APQP process and the ProLaunch process is utilized with suppliers on all launch projects in order to improve efficiencies and reduce cost of launches
Support and/or lead cost reduction initiatives by leading cost-out events and promoting a culture of continuous improvement in the areas of Lean, Quality and Customer Satisfaction
Communicates in writing and verbally with co-workers, management, internal and external customers, and others in a courteous and professional manner
A. Requires a bachelor’s degree in Engineering and a minimum two years of engineering experience as Quality engineer in the design and manufacturing of electrical product
B. Ability to work with minimal supervision
C. Must have good written and oral communication skills , and ability to communicate and work effectively with other employees and departments at all levels of the organization
D. Ability to organize and schedule a demanding work load
E. Excellent analytical and problem solving skills
F. Ability to supervise and motivate the project team to meet scheduling requirement and overall company goals
G. Willingness to work hours necessary to meet schedules
H. Must be proficient with current Microsoft Office software including MS Project
I. Working knowledge of design feasibility reviews, engineering drawings, specifications, control plans, and FMEA’s
J. Working knowledge of prototype production and quality systems and ability to facilitate samples to internal and external customers
K. Working knowledge of inspection tools : CMM, Calipers etc
L. Have experience in ISO 9001/TS16949 quality system establishment and sustaining
M. Knowledge of Six Sigma application in a manufacturing environment
N. Knowledge of lean manufacturing processes

Senior Supplier Quality Engineer Resume Examples & Samples

Train Suppliers to effectively execute Supplier Corrective Action Requests and Corrective and Preventive Actions
Initiate and follow-up Supplier Corrective Actions in partnership with Manufacturing Engineering to ensure complete and effective root cause analysis and corrective action implementation
Develop positive relationships and effective lines of communication with suppliers: Partnership-oriented arrangements
Work closely with the SCM to establish and maintain a Supplier Quality Scorecard
Work closely with Supplier Development Engineering to improve Supplier Quality Performance
Coordinates and controls: Implementation of activities related to Quality System, Process of parts approval/ products, Elaboration of PFMEAs and Control Plans (CP), Creation, implementation and control of correcting actions, Implementation of SPC graphics
Ensure the quality system is followed up at receiving inspection area
Establish controls for all metrics related to supplier quality (DPPM, MRB, etc).Take the ownership and solve all issues related to supplier quality, ensuring no impact to the production lines
Provide all resources and coaching needed to the personnel at incoming area, to perform the receiving inspection function without any production delays
Support the MESH Initiatives and Zero accident culture
Support the Eaton Quality Systems as well as EBE, ISO/TS, etc
Support and/or participate on Continuous Improvement Activities such as: Kaizen, Ideas Programs
Bachelor Degree in Mechanical, Mechatronics or Materials Science Engineering (Preferred)
3-5 years’ experience in the same position
Experience in Supplier Balance Score Cards
Solid and proven experience in lean manufacturing tools and six sigma methodologies
Excellent knowledge using AutoCAD and MS Office Excel, (Excel – Graphs, databases, etc)
Excellent English/Spanish communication skills - must be able to have a conversation at different levels

Senior Supplier Quality Engineer Resume Examples & Samples

You will both work within a team and independently. It is very important that you have ability to create a good relationship with the stakeholders; your suppliers, Purchasing Project Managers, Special Vehicle Development, SQE colleagues & buyers
Project manage SQE activities for S.V. with the responsible SQE and report project status according to relevant DVP milestones
Have SQE responsibility for S.V. unique suppliers carrying out Quality Assurance activities such as
SSEM, SEM
Process Audits
APQP Lite
PPAP/PSW validations
Active participation in supplier related warranty issues for S.V material
Work with suppliers in resolving quality issues using problem solving tools and techniques
Excellent communication & networking skills
Strong analytical & technical skills with the ability to read and understand technical specifications such as drawings, standards and technical regulations
Proven experience with project management
The ability to work both within a team to share experiences, contribute to targets and goals and in particular to work on their own initiative
SEM leader auditor status would be beneficial
Cost calculation and value stream mapping experience with regard to processes and tooling would be extremely advantageous
The candidate will ideally have 5 years, or more, experience within SQA
A degree within Business Management or technical related subject

Senior Supplier Quality Engineer Resume Examples & Samples

At least 8yrs above work experience in Quality Function, Good knowledge of Plastics Injection Molding processes or Packaging manufacturing technologies. Experience in Medical industry is a plus
Good written and oral English skills
Good command of Chinese Language skill(spoken and written) is a must

Senior Supplier Quality Engineer Resume Examples & Samples

Development of a Program Supplier Quality Plan
Supplier performance (root cause analysis, corrective and preventative actions), monitoring supplier performance data to identify trends, analyzing opportunities for continuous improvement, recommending supplier improvement actions including Lean Manufacturing and Six Sigma
Lead and perform First Article Verification and Source Surveillance Activities on Machined parts, harnesses, and backplanes and coordinate with the SQE Manager for additional support when needed
Support the identification, assessment, and qualification of new Suppliers
Perform and support Supplier audits
Internal Raytheon and customer reporting of Supplier performance, issues and strategies
Subcontractor Product Acceptance Plan
Interpret and apply quality notes and quality requirements to purchase to ensure subcontractor/supplier understanding
Ensure flow down of Product requirements both internally and to sub-tier suppliers, ensure compliance with quality requirements
Assess subcontractor/supplier quality capabilities throughout the program life cycle to achieve full program objectives
Identify systemic performance issues ensuring root-cause analysis and corrective solutions are identified and implemented with closure plans
Drive continuous product / process improvements using statistical / analytical improvement tools such as Six Sigma and lean methodologies
Work closely with other Quality functions and Cross Business Teams (CBTs), to affect rapid closure of issues utilizing analytical capabilities and communications skills
Participate in Statement of Work Development, peer review and sign off
Manage and status Subcontract Data Requirements List deliverables
Ensuring that supplier records in program’s Approved Vendor List are current
6+ years’ experience with Engineering, Quality, Supplier and/or Program Management
Experience with Supplier Quality Management
Management, supervisory or team lead experience
Experience with problem resolution of technical and/or quality issues Excellent written / verbal communication and presentation skills
Desired Skills
Experience with assessments of suppliers: requirement flow down, technical data package (TDP) reviews, translation of TDP to manufacturing data package (MDP), product acceptance and process evaluations at supplier’s facilities
Knowledge of manufacturing operations such as machining, PWB fabrication and harness assembly General knowledge of how aerospace and defense specifications/standards are flowed into quality and qualification requirements for purchased material
Experience building and maintaining relationships with multiple customers or partners (both internal and external to the company)
Six Sigma, Lean and / or American Society for Quality (ASQ) Certification (CQE, CQM/OE, CSQE, CQA, CRE, etc.)
Experience with external customer (government) assessments / audits
Periodic travel to Suppliers

Senior Supplier Quality Engineer Resume Examples & Samples

Audit, monitor, evaluate, report and improve supplier Quality system performance and provide technical support to suppliers
Collect and add supplier information required for the Approved Supplier List
Identify and implement statistical engineering tools and techniques to evaluate supplier process capability and technical performance
Collect and analyze Quality metrics relating to Supplier Quality
Identify and define correction actions and follow-up to ensure completeness and effectiveness
Communicate supplier Quality risks to upper management while suggesting improvements and cost savings where possible
Bachelors Science degree (Engineering or Science) is required with 4 years minimum experience in the medical device required, pharmaceutical industry experience may be considered
Experience with class II and class III medical devices a plus
Demonstrated ability to apply statistical Quality engineering tools in a supplier environment
Working knowledge of International and Domestic FDA regulations
Effective problem solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
Strong understanding of Manufacturing processes (i.e. Injection Molding, Extrusion, and Machining)
Thorough understanding of Risk Management principles
Strong communication and organizational skills to effectively manage and get results with external suppliers
Six Sigma Black Belt/LEAN Manufacturing experience preferred
ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor preferred
Domestic and International Travel upwards of 25%

Senior Supplier Quality Engineer C-electrified Powertrain Resume Examples & Samples

Perform supplier quality systems and process audits and lead Supplier improvement/development programs Establish close relationships with assigned suppliers and actively drive continuous improvement activities
Participate in launch teams
Lead and coordinate APQP/PPAP deliverables for purchased components within the supplier quality group
Work with Engineering and supplier organizations to alleviate discrepancies in product specifications and evaluate cost reduction opportunities
Bachelor of Science degree in Mechanical Engineering or Electrical Engineering from an ABET accredited university with a minimum 3.0 GPA
Experience with electric vehicle, electrified powertrain and/or alternative propulsion

Senior Supplier Quality Engineer C-powertrain Resume Examples & Samples

Participation in launch teams for purchased components within the vehicle and powertrain platforms
Bachelor of Science degree in Mechanical, Electrical, Systems, or Computer Engineering from an ABET (Accreditation Board for Engineering and Technology) accredited program
5 years' work experience in the automotive industry in an engineering role
Superior written and verbal communication, presentation, and interpersonal skills
Certified in at least one of Kepner-Tregoe, Shainin Red X, Design for Six Sigma or Six Sigma (Black Belt)
Master's degree in Engineering or other advanced education
Certification in multiple disciplined problems solving methodologies
Work experience with powertrain calibrations

Senior Supplier Quality Engineer Resume Examples & Samples

Minimum 5 years’ experience in a Supplier Quality, Quality Engineering or Reliability Engineering function
Working knowledge and auditing experience to US and international regulatory and quality assurance requirements (FDA 21 CFR Part 820 and ISO 13485) associated with the development and manufacture of medical devices or drug products
ISO 13485:2003 Certified Lead Auditor preferred
6 Sigma and/or Lean experience preferred (trained or certified)
Good analytical and statistical problem solving tools
Working knowledge of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab

Senior Supplier Quality Engineer Resume Examples & Samples

Responsible for specified project implementation and project management
Responsible to develop/qualify suppliers
Develop suppliers to meet qualification requirements, Solve suppliers quality issues and improve performance to ensure meet company quality performance objective
Supplier quality system audit and qualification
Technical Support to design engineers , buyers and suppliers

Senior.supplier Quality Engineer Resume Examples & Samples

Requires a bachelor’s degree in Engineering and a minimum two years of engineering experience as Quality engineer in the design and manufacturing of electrical product
Must have good written and oral communication skills , and ability to communicate and work effectively with other employees and departments at all levels of the organization
Ability to organize and schedule a demanding work load
Ability to supervise and motivate the project team to meet scheduling requirement and overall company goals
Willingness to work hours necessary to meet schedules
Must be proficient with current Microsoft Office software including MS Project
Working knowledge of design feasibility reviews, engineering drawings, specifications, control plans, and FMEA’s
Working knowledge of prototype production and quality systems and ability to facilitate samples to internal and external customers
Working knowledge of inspection tools : CMM, Calipers etc
Have experience in ISO 9001/TS16949 quality system establishment and sustaining
Knowledge of Six Sigma application in a manufacturing environment
Knowledge of lean manufacturing processes

Senior Supplier Quality Engineer Resume Examples & Samples

Operate internal and external reporting system and propose improvement opportunity
Maintenance of updated documentation, specification
Analysis of process related problems
Analysis of scrap, RMA, debate with suppliers
SRMA process
Reporting, statistics
Bridging of customer-supplier relation
Cooperation with involved departments
Supplier audits / development monitoring

Senior Supplier Quality Engineer Resume Examples & Samples

As core member of IPD project team ,coordinate all supplier quality activities , drive collaboration with Development & Suppliers to ensure manufacturability, testability and Quality maturity of designs, support supplier’s IPD activities in pace with IPD project plan
Conduct component release, process release and PSW in IPD as well as LCM&MLU(life circle management and Middle Circle Update)
Create and maintain SRR(Sample Release Request) and IC(inspection Card); train IQC inspectors and suppliers
Quick solve component deviation which is escalated from production, marketing and the other parties, support Field Return Failure Analysis, FCR(Fail Call Request) improvement and Back Charging analysis
Manage quality performance of a group of suppliers, collate and report on supplier quality performance
As MRB (make or buy) member to attend MRB meeting and disposal of MRB material
Deploy supplier quality development plan with a group suppliers and motivate supplier’s quality accountability and maturity continuously
Support localization, repeat mold, and operational projects
Relevant documents maintenance
Supplier audit and assessment, as well as supplier scouting
Support in ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met
Executes SCAR management, effective and timely closure and Review/risk assessment of NC(Non-compliance)'s and their escalation to SCARs(Supplier Corrective Action Request) or CAPA where needed
Competency and Skills

Senior Supplier Quality Engineer Resume Examples & Samples

Provide supplier qualifications, material issue resolution, driving supplier corrective actions, component/BOM validation, supplier audits, and maintain the approved supplier list
Perform internal supplier/purchasing auditing to ISO standard requirements. Documenting procedures necessary to meet ISO practices, where necessary
Maintain and continuously improve the accuracy of test and calibration equipment, process and procedures. Work with suppliers to assure lowest cost most effective and capable systems
Drive corrective and preventive action program, from initiation to resolution of items. Collect and analyze data to track supplier improvement
Develop and manage a true incoming materials quality program to verify the actual state of supplied materials and drive purchased material quality improvement
Assist in the development of relationships with suppliers that are aligned with the business plan both now and future thinking
Will identify world class suppliers that we might want to use as vendors or partners
Assist in the transition to manufacturing and process control of specific purchased material incorporating evaluation, benchmarking and validation techniques including capability studies
Initiate and drive scrap-reduction and cost-savings project teams
Work with Supply Chain and Purchasing Management to drive supplier process and materials compliance to Signal requirements. Work with Engineering and Manufacturing to ensure that all product documentation and products reflect the appropriate marking, labeling, and packaging to meet standard transportation and customer requirements
Initiate documents and maintain the company supplier and purchasing management system w/ supporting data reporting, tracking and auditing
Four Year Degree – Preferably in Quality Engineering, General Engineering or Business
Minimum five (5) years quality engineering experience or supplier quality engineering experience
Approximately 80% Travel
Conversational Spanish
Familiarity with supply chain and purchasing disciplines
Ability to utilize Six Sigma tools to resolve product/process issues
Ability to read, interpret, and understand technical and non-technical documents including but not limited to contracts, product drawings, and product specifications
Proficiency with standard business and specialized software packages
Excellent Communication and presentation skills for external and internal audiences of all levels
ASQ Quality Engineering Certification
Previous auditing experience
Wireless of consumer electronics logistics/repair/manufacturing

Senior Supplier Quality Engineer Resume Examples & Samples

Must be able to coach and communicate effectively with external suppliers/stakeholders and all levels of the organization to negotiate, influence and enforce Quality and Company policies
Bachelor’s degree in engineering, technical engineering or science discipline or combination or equivalent experience
Ability to execute Quality methods and systems (statistics, reliability, sampling, and auditing, problem solving)
Problem solving background
ISO / QS / TS / FDA quality system working knowledge and auditing experience

Senior Supplier Quality Engineer Resume Examples & Samples

Provide Quality Engineering support to suppliers including audits/technical assessments, inspection technique support, verification/validation activities, Corrective and Preventive Actions (CAPAs) and change management
Conduct assessments to Good Manufacturing Practices (GMP), International Organization for Standardization (ISO) and any other applicable standards
Manage supplier related Non-Conformities (NC and SCAR's) and Corrective and internal CAPAs
Utilize industry and process excellence standards on an expert level in daily quality operations Implement Supplier Quality strategy and follow Supplier Quality standards
Support QE with supplier product PVEs (First Article Inspection, Control Plans, Critical to Quality, Capability studies)
Support Procurement executing supplier transfer projects
Partner with the Operations, Engineering and New Product Development group to provide technology assessment and supplier technical support
Minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline
Minimum of 5 years of equivalent experience
Auditing background is an asset. Six Sigma, Lean, or ASQ Certification and trainings an asset
Strong technical writing skills,
Ability to manage multiple projects simultaneously and change priorities based upon business needs
Strong communication & leadership, teamwork, and problem solving skills

Senior Supplier Quality Engineer Resume Examples & Samples

Contributes to the development, maintenance and improvement of SJM supplier development quality program policies, procedures and forms
May provide coaching, and mentoring for technical team personnel
Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
Reviews and approves all supplied product drawings and component quality plans
Provides engineering guidance to SJM Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures
Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews
Evaluates and develops Supplied Data Agreement partnerships with suppliers
Works with Manufacturing engineering to assess and address purchased product issues
Design and conduct experiments for process optimization and/or improvement
Participate in or lead teams in supporting SupplierDevelopment Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
5+ years’ experience
Engineering experience and demonstrated use of Quality tools/methodologies
Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Ability to leverage and/or engage others to accomplish projects
Ability to travel approximately 10-40%, including internationally
Demonstrated supervisory experience preferred
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model preferred

Senior Supplier Quality Engineer Resume Examples & Samples

Work with purchasing to ensure supplier performance is regularly reported and those appropriate and timely corrective actions are implemented
Maintain and update critical supplier audit system and schedule
Conduct supplier audits to drive process standardization, waste elimination, and continuous improvement
Compile data and write associated SCARs
Collaborate with suppliers and extended manufacturing teams regarding performance of product and support the technical team to determine process improvements required to eliminate waste. Drive to improve Quality and On-Time Delivery supplier performance metrics
Develop long‐term supplier relationships and generate and implement cost reduction ideas
Oversee manufacturing and engineering in the evaluation and qualification of new supplier materials following a defined new product development process
Strategically lead supplier performance improvement projects in an effort to increase the supplier capability of consistently meeting Cobham requirements. Projects may include: process analysis, value stream mapping, process capability and throughput analysis, 6‐Sigma, 5S and Kaizen events
Create procedures or work instructions related to Designated Supplier Quality Representative (DSQR) Dock-Stock Strategies, Supplier Management, and supplier performance metrics
Assist suppliers as a communication conduit between Management, Design Engineering, SQEs and Suppliers when all other modes of communication have failed to deliver acceptable results. Such as systemic problematic items including: product form, fit, and function, compliance documentation, and process error proofing driving manufacturability issues
Train Suppliers in basic Root Cause/Corrective Action, Process Mapping and Problem solving. Communicate / train engineering and manufacturing specifications to supplier technical teams. Conduct supplier training on quality, process, and on-time delivery topics
Interprets engineering drawings and specifications, customer quality requirements, and company quality requirements to ensure compliance with the customer's expectations
Review design concepts and technical documentation; collaborate with suppliers to assure their understanding
Develop error proofing (poka yoke) strategies collaborating with suppliers. Work with design engineering and operations to develop producibility and testability strategies / techniques. Perform necessary tests with equipment and effectively document test results
Travel up to 50% (typically 20% to 35%) and ability to obtain and hold a passport
Defense Contract Management Agency (DCMA) experience
Experience with regulatory requirements, Government/Military contracts, Military aviation or aircraft modification experience
FAA experience, experience with FAR Part 145 and 21 FDA experience
Black Belt Certified
Experience working in an Aerospace Industry

Senior Supplier Quality Engineer Resume Examples & Samples

Lead investigations to determine root causes on material quality issues and initiate/ensure corrective and preventive action plans are developed and executed
Compile and evaluate supplier/CM quality performance metrics
Ensure that supplier’s preventive and corrective action is implemented and effective
Provide monthly quality data/input for suppliers/CM’s Scorecard
May train new engineers and associates
Other such duties that may be determined by Management

Senior Supplier Quality Engineer Resume Examples & Samples

BS in Engineering (or equivalent) and a minimum of 2 years engineering work experience in the medical device industry, 4 plus years if experience is a non-life science industry
Practical experience/familiarity with regulated environments, i.e. ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, ISO 14971 and other applicable standards
Must have relevant experience with supplier quality systems/processes including Supplier Corrective Actions (SCAR), First Article Inspection (FAI), Incoming Inspection Plans (IP), and supplier audits
Must possess practical knowledge related to the products/components that the position will support, e.g., electromechanical product components and assembly processes
Must have competent PC skills and be highly proficient with Microsoft Word, Excel, and PowerPoint. Experience using Minitab statistical software is desirable
Must have practical knowledge and experience in statistical analysis, problem-solving/process improvement techniques, and Root Cause Investigation/CAPA
Familiar with the proper use of common inspection tools, test equipment, and visual standards
Must be able to read and understand component/product specifications
Effectively partners with suppliers to ensure Medivators products conform to specifications and quality standards while driving continuous improvement with vendors
Implement FMEA/risk-based incoming inspection processes and lead quality at the source initiatives
Systematically monitor risk in supply chain through the vendor approval process, onsite assessments, and supplier metrics
Communicate quality issues to suppliers and the value stream through proactive relationships
Evaluate proposed changes at suppliers and support change management
Design and/or specify inspection and testing procedures/systems
Lead the supplier corrective action process (SCAR) and investigate/analyze in-house and field failures (complaints), and improve product quality by determining root cause and recommending corrective actions
Propose, recommend, and oversee implementation of component and process improvements based on quality trends
Participate in investigation and analysis of customer complaints and field service trends
Review and approve disposition for Nonconforming Product and support Material Review Board (MRB)
Author, review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures related to supplied components
Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance
Support all functional departments to ensure compliance with Medivators Quality System and lead continuous improvement efforts of the Quality System
Be key participant in CAPA Committee and any Data Review Committees
Closely partner with Purchasing/Planning commodity teams and interface with personnel from all areas of the company to foster improved quality and efficiency
Communicate supplier quality metrics and project status to Focus Factory leadership
Utilize QA Inspectors and Technicians as resources and key partners in Quality

Senior Supplier Quality Engineer Resume Examples & Samples

Monitor QCS Codes to ensure applicable to the Purchase Specification on Purchase Orders
Monitor documentation issued with Purchase Orders to ensure the latest revisions are supplied
Work with Engineering to identify high risk processes used by suppliers and ensure adequate process validation is in place (First Article Inspection)
Monitor Change Controls at suppliers to ensure deviations from agreed processes and specifications are adequately controlled
Ensure the Supplier ITP process is adhered to
Ensure Witnessed Inspections are controlled
Ensure all required Supplier Records are received, validated and stored in a controlled manner
Work with Engineering to ensure Vendor Categorisation of suppliers is correctly aligned to the level of risk associated with the the product being supplied
Review and assist in the development of the Vendor Approval Process including requirements for Supplier Audits
Monitor corrective and preventative actions for supplier deviations and contribute to PM@Siemens PACT Workshops and Lessons Learned when required
Monitor alignment to the network SQM Policy
Assist in the development and delivery of a Patrol Inspection Process including expediting
Experience in Operations, Supply Chain or Quality Management and a good understanding of the business
You must clearly demonstrate the ability to deliver a systematic methodical approach, determination and good interpersonal skills
LI-MS

Senior Supplier Quality Engineer Resume Examples & Samples

4+ years of experience with a Bachelors
2+ years of experience with a Masters
Experience in a regulated environment
ASQ Certified Quality Engineer preferred
Electrical Design and/or fabrication experience
Electrical IPC-A-610 standards
ISO13485 Lead Auditor Certified
Motivated self-starter who performs with little supervision
Proven history of driving continuous improvement

Senior Supplier Quality Engineer C-engine Systems Resume Examples & Samples

Bachelor of Science degree in Mechanical Engineering or Electrical Engineering from an ABET accredited university; Bachelor's degree in Aerospace/Aeronautical, Biomedical/Biomechanical/Bioengineering, Chemical, Materials, Metallurgical, or Mechatronics may also be considered
4 ½ or more years of work experience in Supplier Quality, Quality, Engineering, Manufacturing, or a related field
Proficient in using Microsoft Office Suite software

Senior Supplier Quality Engineer C-plant & IRF Resume Examples & Samples

Develop, present, and explain program status updates to senior leadership
Manage multiple individual work teams and work globally
Provide clear communication
Manage Supplier Quality activities for NAFTA purchased parts
Work with suppliers and affiliate plant personnel to manage the containment and root cause analysis studies being coordinated at the affiliate manufacturing facility
Educate plant staff on FCA Supplier Quality systems and requirements
4 1/2 or more years of overall work experience in quality, engineering, production, manufacturing, or related fields
Master's Degree in Engineering or an MBA

Senior Supplier Quality Engineer C-supplier Quality Operations Resume Examples & Samples

Provides warranty management training to internal and external customers
Works cross functionally with Engineering, Manufacturing, Supplier Quality, Corporate Quality, Purchasing, and suppliers to ensure that warranty concerns are effectively and rapidly mitigated
Serves as a liaison and facilitator between all business units to assist in addressing and resolving warranty system or policy issues
Bachelor of Science in Engineering from an ABET accredited university or related Bachelor's degree with 5 years commensurate experience
Effective presentation, written and verbal communication skills
Proficient in use of Microsoft Office Suite software, with expertise in PowerPoint and Excel to include the use of pivot tables, VLOOKUPS, and macros

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelor’s degree with preferred major in Industrial, Mechanical or Electrical Engineering
Five (5+) Years’ experience working in manufacturing, supplier or quality engineering functions with electrical or electromechanical products
Comprehensive knowledge of ISO 9001, Auditing Practices and Quality Systems
Position will require some travel (10%)

Senior Supplier Quality Engineer Resume Examples & Samples

5-8 years experiences in mfg / enterprise environment
Fluent English communication skills on read/writing and oral
Fluent in English, with good communication skill
High energy with 5 years of manufacturing background

Senior Supplier Quality Engineer Resume Examples & Samples

Maintain supplier performance and audit results
Identify repeat quality issues by supplier and maintain supplier quality scorecard
Candidate must possess a Degree or Diploma in Electrical/Mechanical Engineering with minimum 5 years' experience in an engineering/quality capacity in a manufacturing environment
Strong technical background and knowledge in heater/ cable/ charger/ Cordset/ Power Supply manufacturing processes will be of added advantage
Extensive experience is specifically required in issue management techniques, tools and methods e.g. 8D, 5 Whys, 5S, GR&R, DOE etc
Issue Management - Able to successfully manage complex issues whilst under time and cost pressure, lead / coordinate cross-functional teams in delivering timely solutions
Experience in working in an environment where specification and process are not always predetermined
Analytical and data driven with an ability to generate a concise argument to support their views
Motivated by driving continuous improvement programs and application of Lessons Learnt mindset

Senior Supplier Quality Engineer Resume Examples & Samples

Candidate must possess a Degree or Diploma in Electronics / Materials / Mechanical Engineering with minimum 5 years' experience in an engineering/quality capacity in a manufacturing environment
Strong technical background in SMT/PCBA manufacturing and Quality management
Familiar with soldering materials, PCB, components, cable hardness testing & acceptance criteria. Knowledge with or certificate with SMT, IPC- A600, IPC-A610, IPC-A620 will be plus point
Extensive experience is specifically required in issue management techniques, tools and methods e.g. 8D, 5 Whys, 5S, GR&R, SPC, DOE, FMEA, PDCA, DAMIC etc…
Knowledge and experience in project management will be plus point

Senior Supplier Quality Engineer Resume Examples & Samples

Improves products through implementation of quality management policies, procedures, specifications, test methods and measurement systems
Develops new and/or improved processes and techniques for engineering tasks
Develops risk management plans, reports, and utilizes risk management tools such as FMEAs
Responsible for review and approval of drawings, calculations, and specifications
Coordinates and executes the purchased part approval process (PPAP)
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Provides trending analysis on quality issues and performance metrics
Develops and updates Quality Plans
Coordinates and participates in elements of investigations regarding customer complaints
Minimizes customer complaints due to product quality through effective corrective action and preventive actions
Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN)
Performs product and process evaluations to identify areas for improvement. Recommends solutions to identified problems. Implements approved changes using sound Quality Engineering principles and fully documents requirements on a timely basis
Works closely with Manufacturing Operations to identify and resolve production and quality system deficiencies
Assists in regulatory reporting activities
Provides direction in implementing Incoming Inspection Plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and test acceptance criteria, and resolves nonconformances
Coordinates supplier deviation/supplier corrective action request (SCAR) process
Performs vendor audits and qualifications
Uses quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies
Supports the validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product
Initiates and directs corrective actions to problems relating to product or process quality
Communicates essential Management Review data to senior leadership such as complaint trending and analysis
Responsible for the DHR review and approval process to support the release of contract manufactured product in a timely manner
Analytical – Strong statistics knowledge as it relates to new product development. Strong analytical skills. Critical thinking for investigational purposes
Communication
Adaptability
Computer Skills – Proficient computer system based tools including Microsoft Office applications (i.e., Word, Excel, PowerPoint, Outlook, Project, etc.), e-mail, web browsers and spreadsheet software
Minimum of 7 years of experience with Quality Engineering in the food, drug, or device industry required
Medical device Quality Engineering experience strongly preferred, but not required
Supervisory experience strongly preferred, but not required

Senior Supplier Quality Engineer Resume Examples & Samples

Supplier Quality Management/Experience
Excellent Interpersonal and Communication skills
Knowledge of quality system requirements
Formal training and experience in auditing preferred
Demonstrated skill in root cause analysis and corrective action implementation
Understanding of QSR in the medical device industry
Excellent oral, writing, and presentation skills
Basic computer skills including Microsoft applications, and database management
Engineering background including expertise in production environment in the medical device field preferred
Ability to deliver innovative, cost-effective and timely solutions in a multiple project environment
Understanding of continuous improvement methodologies including lean, six sigma, and validation
S. in Engineering or technical discipline with at least 6-8 years of experience including relevant supplier quality and experience
CQE and CQA certification preferred

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelor of Science degree in Engineering (Mechanical, Industrial, Electrical, Manufacturing, or equivalent technical experience)
Excellent oral, written and presentation and communication skills
Experience using problem solving tools such as 8D, Red-X, DFSS, 5 Why, and Fishbone
Three to five years’ OEM or Tier 1 experience in powertrain quality, manufacturing or engineering functions, including demonstrated experience and capability in any of the following areas

Senior Supplier Quality Engineer Resume Examples & Samples

Five (5+) years’ experience in a manufacturing environment
Prior problem solving experience in manufacturing via an analytical approach using continuous improvement methodology
Strong project or program management skills

Senior Supplier Quality Engineer Resume Examples & Samples

Oversee the Supplier Quality Management operation, which consists of a team of Quality Engineers responsible for supplier quality management
Support the Supplier Management Council team, responsible for supplier approval and selection
Manage Supplier Audit Schedule, and ensure the Supplier Quality Management team is supporting all necessary supplier audits/visits
Develop processes and procedures to ensure compliance to Quality Management System (QMS) requirements
Maintain Approved Supplier List and ensure documentation and records required for supplier approvals are controlled and current
Support Supplier Management Team with supplier audits in support of supplier evaluations (new and recurring), supplier selection, pre-conformity inspections, First Article Inspections (AS9102), and supplier quality performance improvement initiatives (as needed)
Manage Supplier Corrective Action Requests (SCARs) and Nonconformance Report (NCR) database and reporting metrics
Manage Failure Reporting Analysis and Corrective Action System (FRACAS) and reporting metrics
Review and report Supplier Scorecard performance, and ensure underperforming suppliers have corrective actions in place to address performance issues
Support Supplier Performance Review meetings to discuss Supplier Scorecard results and improvement plans
Review Supplier Scorecards and Supplier Quality Metrics; report results and action plans to senior management
Support Failure Review Board (FRB) and Corrective Action Board (CAB) meetings to enhance product and service improvements
Work with cross functional teams including Engineering, Program Management, Manufacturing, Supply Chain, Configuration Management, Legal, Contracts, and Operations in support of continuous improvement initiatives
Conduct supplier contract reviews including Purchase Orders, Terms and Conditions, Statements of Work, and supplier agreements to ensure adequate supplier requirements are flowed down
Review and approve Engineering Change Orders (ECO) and submit Engineering Change Requests (ECR) as required
Support and implement strategic initiatives around improved supplier quality performance
Undergraduate degree in a technical discipline and a minimum of 10 years of relevant quality engineering experience in the aviation/aerospace industry, or a Graduate degree and a minimum of 5 years of relevant quality engineering experience in the aviation/aerospace industry
Able to demonstrate knowledge in FAA regulations and requirements pertaining to the commercial aviation industry, including CFR Part 21 and 145, orders, guidance, directives, etc
Must be familiar with AS9100 and ISO 9001 Quality Management System requirements
The candidate shall be able to demonstrate proficiency in reading and interpreting engineering drawings and schematics (mechanical & electrical), with a basic understanding of GD&T
FAA Airframe & Powerplant certifications preferred
Six Sigma Green Belt and ASQ certifications preferred
Excellent communication and collaborative skills required
Proficiency in Microsoft office, SharePoint, Oracle Agile PLM, and Navision ERP systems preferred

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelors of Science degree in Electrical, Mechanical, Industrial, or equivalent technical degree
Minimum 5+ years of experience
Experience across different electronics component/electro-mechanical assembly technologies and technical background in design and manufacturing of PWB and SMT process/technology, electronic assembly processes, IPC standards especially IPC 610-D Class 3 workmanship standards
Experience/Knowledge in Quality Systems (ISO 9000/TS16949)
Experience in management of OEM/ODM suppliers in Asia/Asia-Pacific region
Ability to interact successfully with all levels of supplier’s organization, from Sr. Management to direct labor personnel at factory both domestic and foreign
Ability to travel on short notice
Experience/Knowledge of RoHS, RoHS 2, REACH and WEEE initiatives and compliance regulations worldwide
ASQ certified engineer

Senior Supplier Quality Engineer Resume Examples & Samples

Document systems and processes for purchasing controls and supplier management to ensure compliance with internal, FDA and regulatory requirements
Conduct and document supplier audits, and manage resulting corrective actions with suppliers
Participate in plant CAPA activities, including analysis of trends in supplier quality and coordination of corrective/preventive action with suppliers
Establish effective inspection techniques in conjunction with internal Quality Control and suppliers
Assist with measures of supplier capability such as Cpk and Ppk
Perform Gage R&R studies, as required
Participate in supplier selection process
Monitor new product introduction (NPI) processes at suppliers
Be prepared to represent purchasing controls and supplier management during regulatory inspections
Primary Quality Assurance representative to the Supplier Steering Committee (SSC)
Travel will likely exceed 25%
Bachelor’s degree in a technical field with 5-7 years of work experience or equivalent experience in related industry
Ability to effectively communicate written and verbally
Working knowledge of standards including, but not limited to, ISO 9001, ISO 13485, 21CFR Part 820, UL 61010, IPC-A-610/620 and sampling plans such as ANSI Z1.4/1.9 and C=0
Ability to read and understand engineering drawings for electromechanical components and assemblies, including knowledge of GD&T
Understanding of change management and design control processes
Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) desired
Familiarity with the following commodities is desirable

Senior Supplier Quality Engineer Resume Examples & Samples

Work with suppliers to quarantine all suspect and non-conforming material
Issue supplier corrective action requests, and drive suppliers to identify and address true root cause
Participate on supplier audits, as required
Train/educate suppliers on GMP, regulatory requirements, and Stryker expectations
Manage supplier initiated changes; serve as the “change owner” in Stryker’s change management system
Serve as a subject matter expert, for your assigned commodity; share expertise within global Stryker organization
Disposition material quarantined in MRB
Foster strong relationships with Stryker’s supplier-partners
Analyze non-conformance data to prioritize projects and to solve systemic supplier issues
Drive continuous improvement actions with suppliers to reduce part related defects
Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection
Train/educate suppliers on Quality topics: Quality System, problem solving, validation, and lean
Push “lessons learned” from the supply base back to R&D for incorporation into next generation designs
BS in engineering, or engineering related discipline required
ISO-13485 Lead Auditor certification preferred
3+ years of relevant experience in Quality, Project Management, or Engineering
Experience in medical device industry preferred
Experience working onsite developing suppliers preferred
Experience conducting supplier audits and internal audits preferred
Demonstrated collaboration, negotiation, and conflict resolution skills
Familiarity with quality systems; ISO13485 & ISO9001 experience preferred
Experience in production and process controls
Expertise in problem solving and root cause analysis
Working knowledge of quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts

Senior Supplier Quality Engineer Resume Examples & Samples

Pre-paint substrate preparation to ensure adhesion of paint is robust and passes all specifications
Paint & powder coat application methods and optimal conditions
Post paint oven cure processes, including oven & material profiling and qualification
PCI (Powder Coating Institute) 3000 & 4000 audits and related audit experience
Paint Supplier qualification programs
Engineering aptitude to diagnose paint, thickness, color, adhesion, and curing issues
Manages supplier qualification projects and provide regular update to CFT teams
Interface with internal customer on quality issues and actively participate in failure analysis and corrective action efforts
Aid in administering the supplier quality program
Requires frequent travel to suppliers to understand their processes and controls, verify controls are executed as planned, and communicate issues encountered by UCT and work directly with the supplier to improve processes and part quality
Provide executive summaries to the Director of Quality and report out monthly as part of the UCT Quality Ops Review regarding supplier quality-related performance
Obtain and maintain supplier process control information and work with the purchasing department and suppliers to resolve major quality issues as necessary
Maintain systematic reporting for suppliers on their quality performance
Hands-on experience with ISO 9001 or equivalent quality management systems and tools
Experience in or knowledge of standard fabrication practices of structural frame, sheet metal fabrication and powder painting
Strong knowledge and hands on work experience in secondary process qualification, lab analysis and test
Main focus is powder coating process for structural frame and sheet metals
Secondary process experience/knowledge such as anodizing, surface coating (Ni, Ag, Zn, Cr..), material conversion process (Zinc phosphate, Iron phosphate..), electro polishing, precision chemical cleaning and etc
Hands on experience on supplier assessment, qualification, audit and management
Strong passion and an aptitude for problem solving in a collaborative team environment is required
Ability for good written and verbal communication of technical content in English is required
Strong project management skills is required
Hands on knowledge of problem solving methodologies (8D, 5 why’s, DOE etc.) and quality engineering experience is required
Working knowledge of SPC programs such as Minitab is desired
Working knowledge of Microsoft Software – Excel, Word, and PowerPoint is required
10+ years related experience in high-technology manufacturing, preferably in semiconductor capital equipment or related industry

Senior Supplier Quality Engineer Resume Examples & Samples

Lead supplier audits including pre-audit supplier research, audit planning, audit team coordination, audit report writing and audit finding follow-up to ensure suppliers have quality systems compliant to applicable standards
Select, evaluate and document the addition of new suppliers
Lead supplier change requests including the evaluation of the change, related validation activities and documentation of the change
Lead supplier corrective action activities by analyzing data for trends, evaluate root cause and implement action plans utilizing appropriate risk management and statistical techniques
Lead improvement projects on supplier related procedures and processes both at the supplier and internally using Six Sigma and Lean techniques
Establish and maintain supplier metrics for monitoring supplier performance
Act as technical liaison between product development, manufacturing, external manufacturers and suppliers as needed
Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA and MDD requirements
This job may require up to 30% of both international and domestic travel
Knowledge of ISO, FDA and MDD regulations
Knowledge of metrology tools and inspection techniques is preferred
Six Sigma or Lean improvement certification is preferred
Knowledge of statistics, sampling planning and risk assessment (FMEA)
Ability to communicate effectively across functional organizations and at different management levels is required
Certification by ASQ or equivalent organization in lead auditing and auditing experience is preferred
Strong engineering skills in design verification/ validation and process verification/validation
Past expertise in Project Management skills such as the implementation of new product launches, new quality systems or reduced sampling plans
Demonstrated Technical writing experience (i.e inspection procedures, procedures, protocols, final reports, etc)
A minimum of a Bachelor’s degree in Engineering or technical field or equivalent experience is required; advanced degree is preferred
4 – 6 years’ experience required in medical devices or related field
Combination of education and experience may be acceptable

Senior Supplier Quality Engineer Resume Examples & Samples

To identify, manage and develop Dyson key suppliers by establishing alignment between Dyson requirements, supplier processes & capabilities and performance metrics
To engage Dyson interfacing teams and functions beginning from NPD/I (New Product Development/Introduction) phase for all product categories through to end of product life
Candidate must possess a Degree or Diploma in Engineering with minimum 5 years' experience in an engineering/quality capacity in a manufacturing environment
Strong technical background in moulding/spray painting, metal-stamping, rubber, packaging and Quality management
Extensive experience is specifically required in issue management techniques, tools and methods e.g. 8D, 5 Whys, 5S, GR&R, DOE etc…

Senior Supplier Quality Engineer Resume Examples & Samples

Assess supplier compliance with the Quality System Regulations based on key performance metrics including audits, quality objectives, and complaints
Assist in the development of Supplier Quality programs and processes designed to improve supplier performance and productivity
Assist in the scheduling, planning and performance of Supplier Audits
Provide consultation as necessary to suppliers regarding investigations and the development and implementation corrective and/or preventive actions
Assist with management of active SCARs through the Corrective Action Board (CAB)
Assist with the management of active CAPAs when required
Serve as Quality Administrator for the SCAR system and support the CAPA Quality Administrator role when required
Conduct internal audits for evaluation of compliance with the Quality System Regulations when required
Provide consultation as necessary to the internal audited functions regarding investigations and the development and implementation corrective and/or preventive actions when required
Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to reflect supplier audit and SCAR status and monitor trends
Assist in the preparation of other Quality System reports when required
Support Quality System training as required
B.S. in Engineering or Life Science Related Field
5-7 + years related quality assurance, quality system experience or an equivalent combination of experience and education. Medical device experience required. Previous quality system audit experience required
Lead Auditor Certification preferred
Advanced knowledge of FDA Quality System Regulation 21 CFR Part 820 as well as ISO13485
Good organizational, attention to detail and follow-through skills
Excellent verbal communication and customer interface skills
Ability to interface with multiple suppliers and multiple groups within the organization
Systems - Basic computer skills – word processing, spreadsheet, windows. MS Office preferred. Previous experience with Agile a plus
Willingness to contribute to other departments as necessary
Ability to travel 30 to 50% of time- domestic and global

Senior Supplier Quality Engineer Resume Examples & Samples

Minimum 5 years experience in consumer products quality control, especially in supplier quality and component( subtier supplier) level quality
Strong capability in NPI activities by working with cross function team to make sure quality inputs/voice has been fully adopted and implemented in the early phase of projects
Knowledge of critical component management in famous consumer company as a plus

Senior Supplier Quality Engineer Resume Examples & Samples

Interfaces with Site Supplier Quality, Global Sourcing and Site Integrated Supply Chain (Procurement / Quality, Manufacturing / Engineering) groups to develop and execute supplier development plans to achieve world-class performance in the supply chain
Defines Supplier on-site project scope and develops project plans. Determines appropriate application of improvement techniques such as process mapping, PFMEAs and control plans to maximize results
Cultivate partner-style relationships with suppliers and up-front agreements on supplier commitment, projects, timing and measurement of results. Manages all phases of the project life cycle including the tracking and monthly status reports
Works under minimal supervision, performs wide range of assignments (Specific Audits, Six-Sigma based improvement projects, etc.) using mature judgment and expertise to develop solutions to specified problems
As a member of Honeywell Aerospace Global team you will be directly responsible for a number of allocated suppliers, reporting directly to a Regional SDE Manager
Bachelors degree in engineering or relevant discipline
Robust technical knowledge with excellent communication skill, ability to develop a strong partnerships with the suppliers
Multilingualism is an advantage to cover wider grounds across EMEA region
Experience with working in a manufacturing environment is a plus
Lean Experts will onboard smoothly
The ability to motivate yourself to work as part of a remote team and the flexibility to travel is really important
Aerospace or Automotive experience is advantage
You are self-motivated, energetic team player, ready to tackle challenges ahead

Senior Supplier Quality Engineer C-electrified Powertrain Resume Examples & Samples

Bachelor of Science in Electrical Engineering, Mechanical Engineering (with Electrical Experience), Chemical Engineering, Material Science Engineering and Aerospace Engineering from an ABET accredited or equivalent university
5 or more years of experience in electronics industry with working knowledge in quality, engineering or manufacturing
Electrification Powertrain and Associated Components
Working knowledge of full, partial and mild hybrid vehicle electrical systems including Power Management (High/Low Voltage, batteries, inverters, charging systems) and drive systems is a plus
Working knowledge of quality systems TS16949, ISO 9000/1, be able to support product qualification, and a familiarity with assembly issues related to quality
Working knowledge of Power IC and Powertrain specific semiconductor devices is a plus
Problem solving skills: Green Belt or Black Belt, Quality Certifications: CQE, CRE
Effective written, verbal communication skills and proficient interpersonal skills and the ability to work effectively in a cross-functional team

Senior Supplier Quality Engineer Resume Examples & Samples

Direct activities with their supply and commodity base
Mentor junior personnel in the department
Oversee corrective preventive action
Work with both supply and other SBU supply bases
6+ years of progressive supplier quality or process quality experience and / or 5+ years’ experience in PWA/ PWB circuit cards and flex assemblies with few years of progressive supplier quality or process quality experience
Detailed knowledge of standard AS9100, ISO 9001 Quality Systems and Supplier Management Requirements; and First Article Requirements per AS9102
Strong experience with Microsoft Office Suite particularity in Outlook, Excel Power Point & Word
SAPS experience highly desired
UP TO 50 % Travel maybe required for this position
Due to projects/programs this positions requires an US Citizen

AMZ Robotics Senior Supplier Quality Engineer Resume Examples & Samples

Work with AR Tech Ops Engineers and our suppliers to investigate material and manufacturing process issues to develop containment, corrective, and preventative action plans
Review data collected to identify areas for improvement or to identify trends of causes or symptoms and if resulting in supplier performance then you need to drive the investigations and hold the supplier accountable for their actions and timing associated
Work with suppliers’ to develop sound plans, work instructions and develop systems that will allow their products and process to meet our requirements and be sustainable throughout the product life cycle
Lead Engineering, Tech Ops, and Supply Chain teams in supplier capability assessments to help develop a strong strategic supply base. Includes on site-auditing & support
Work with Supply Chain and Commodity Managers to develop new strategic sources & partners
Work with Tech Ops Engineering to review supplier documentation, processes, and samples to determine the supplier’s readiness to provide production level materials. Could include support in Alpha and Beta stages. On-going production support is required
Has a “hands on, roll up your sleeves” approach to working with others to accomplish short and long term goals in a dynamic environment
Analyze data and trends on a regular basis and populate slide decks for regular scheduled Quarterly Business Reviews (QBR). Generate slides depicting the suppliers’ past quality performance
Learn Agile and use NCR and CAPA data bases. Also, learn SharePoint and use all sources within the Quality Database
4 year Degree AND/OR relevant and extensive experience
5+ years of experience in Quality Engineering. Manufacturing environment is a plus
Experience with statistical process controls, 8D Problem Solving, and Statistical Analysis
Experience and understanding with Design for Manufacturability, GD&T, fixturing, PFMEA, and development of Control Plans. Background in ISO 9001, TS or 13485 is a plus
Experience with internal and external quality systems auditing. Process auditing skills is a plus
Versatile Team player who can lead when required or provide support and expertize for team activities
Strong communication skills, both written and verbal. Must be able to stand before an audience of his peers, leadership and/or supply base and deliver an effective and succinct message
Strong understanding of Quality concepts and tools, such as SPC, Corrective Action Investigation, Lean Manufacturing, 5S, Six Sigma, FMEA. Fishbone diagrams, and 5 Why
Ability to travel domestically and internationally, must have valid passport and driver’s license
Ability to meet deadlines on projects, programs, or tactical directives

Senior Supplier Quality Engineer Resume Examples & Samples

Issues resolution with suppliers – investigating challenging issues with significant business impact
Developing and maintaining suppliers – executing Supplier Business Reviews, audit related activities and deep dive Technical Assessments at suppliers. Development/negotiation of Quality Agreements with suppliers
Supplier process changes – assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities)
A minimum of 4-6 years Quality/Manufacturing experience or related experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is preferred
Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is preferred. An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred
Auditing experience is preferred. Strong root cause analysis skills are required. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred

Senior Supplier Quality Engineer Resume Examples & Samples

Understand Quality System requirements and adhere to Hill-Rom procedures and instructions
Interface with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements. Drive corrective and preventive actions at the supplier to preclude recurrence of identified issues
Lead supplier new part qualification activities, including development of capability studies and control plans that define the supplier’s processes and identify areas of risk. Review and approve engineering design changes and supplier change requests to determine part re-qualification needs
Perform periodic trending and review of supplier-related quality data. Institute quality tools and programs that focus on identification and prevention of quality defects. Participate in root cause / failure analysis of supplier-caused non-conforming product, and ensure company concerns are adequately addressed by the supplier
Measure and communicate supplier performance on key quality metrics and the corresponding continuous improvement plans. Ensure supplier report card process is in place and routine Supplier Business Reviews are scheduled and conducted
Develop and drive departmental projects such as reducing the need for incoming inspections, vendor to stock improvement, electronic certificates of conformance, and re-evaluation process improvement
Must be willing and flexible for business travel as required (supplier audits). Travel required may be upwards of 30%
Bachelor of Science in Engineering or related technical field required (Mechanical, Electrical, or Biomedical preferred)
6+ years of manufacturing, quality assurance, and/or engineering experience required
Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) required
Working knowledge of standard quality system requirements (ISO 9001, ISO 13485, Medical Device Directive, Canadian Medical Device Regulation) preferred
Supplier quality experience in medical device or related GMP environment preferred
Practical experience in metrology, test, inspection, and analysis techniques required
Computer competency in Word, Excel, Powerpoint, Outlook required. Minitab preferred
Ability to operate independently, communicate effectively, and successfully manage multiple responsibilities required
Leadership skills with a passion to embrace positive change for on-going operations and new initiatives required
Fluency in English language required
ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus

Senior Supplier Quality Engineer Resume Examples & Samples

Applies modern quality principles, concepts and methods, including Lean Manufacturing, Six Sigma, DMAIC and process management tools to continuously improve processes, reduce cost and ensure the quality of our products and services
Interprets engineering drawings and specifications, customer quality requirements and company quality requirements to ensure compliance with the customer's expectations and Honeywell TS Quality requirements, and best practice
Drives corrective and preventative action activity both in-house and at the supplier, and provides corrective action support to manage timely and effective problem closure and recurrence control. Experience with 8D. 5Why, cause/effect, and similar root cause analysis tools
Participates in design reviews (APQP) to identify feasibility issues and opportunities early in the product life cycle, in partnership with commercial and engineering teams
Provides a clear and concise flow down of product definition and quality requirements to suppliers
Experience with mechatronics, stamping, heat treatment, actuation, or electrical engineering is a plus

Senior Supplier Quality Engineer Resume Examples & Samples

4+ years relevant experience which may include semiconductor fabrication, engineering, manufacturing and quality
Demonstrated experience in semiconductor fabrication or semiconductor Physics or MEM fabrication
Demonstrated experience in high tech
Proficient in reading and understanding mechanical drawings
Proficient in the use of Six-Sigma tools (PFMEA, PARETO chart, 5-WHYs, GAUGE R&R, etc.)
Demonstrated experience with Statistical Process Controls (SPC)
Proficient with Root Cause & Corrective Action (RCCA) tools
Ability to travel domestically up to 30% of the time
Demonstrated experience in the management of suppliers
Infrared industry experience
Familiarity with quality systems
Familiarity with aerospace industry and its requirements
Experience with LEAN concepts
Bachelor’s Degree in an Engineering discipline

Senior Supplier Quality Engineer Resume Examples & Samples

Lead the BES-Dymax Material Review board and assist in the investigation of component defects and failures,
Participate on New Product Development and Project Transfer teams to facilitate the approval and transfer of suppliers into the BES-Dymax supplier management system
Assist Materials and Engineering in the selection of new suppliers, and conduct qualifications and/or surveillance audits of new or established suppliers to BES
Track supplier performance and prepare and issue monthly reports of supplier and material quality performance, issues, and actions
Issue Supplier Corrective Action Requests as appropriate in response to detected supplier quality trends, and follow-up with suppliers on root cause investigation and closed loop corrective action
Plan and perform component, supplier, and process qualifications including First Article Inspections, and the preparation of written test protocols and reports
Provide supplier related quality assurance sustaining engineering support to established product lines
Work with suppliers to identify and support process and product improvements in support of quality and cost improvement projects
Develop quality inspection processes, tests, techniques, tools, and fixtures, and train the production, service, and quality control staffs as needed to perform their respective duties
Develop written quality plans, and quality inspection and test procedures
Create and review Risk Assessments and Rework Plans for component and product related issues including use-as-is and rework dispositions
Design and conduct Quality Engineering studies to determine causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them
Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects
Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
5-7 years of experience in the manufacture of Electro-Mechanical devices
3-5 years experience in an FDA regulated Medical Device Manufacturing environment preferred
Team leader / player comfortable communicating with broad audiences
A solid understanding of the FDA QSR and/or ISO 9000/ISO 13485 Quality System Requirements specifically in design controls and design transfer and supplier controls
Excellent oral and written communication skills to prepare written technical plans and reports in support of engineering changes, product or process validations, and component qualifications
Strong project planning skills and a strong focus on meeting customer needs
ASQ Certified Quality Engineer, a plus
ASQ Certified Quality Auditor, a plus

Senior Supplier Quality Engineer Resume Examples & Samples

Participating in NPI and STP (supplier transition project) and taking the lead on supplier quality related activities, such as SRR (supplier readiness review) and first article approval
Analyzing selected materials, together with the commodity management, team to identify the best candidates parts for localization
Possessing and expanding knowledge of various commodities and manufacturing processes to maintain expertise and be a local expert for Sourcing. Able to train the suppliers to develop their performance
Bachelor’s Degree in Mechanical or Industrial Engineering
At least 5 years work experience as SQE and/or SDE, including the identification, selection, development and management of global suppliers
Must have demonstrated understanding of APQP concept and PPAP or FAIR processes and implementation
Background in machining, casting, or sheet metal forming, along with processes such as heat treating and metal finishing is also preferred and considerable for candidacy
Previous responsibility for achieving business objectives: ppm and defect reduction, cost reduction, lead-time reduction, on-time delivery, and new supplier launches

Senior Supplier Quality Engineer Resume Examples & Samples

Work with Sourcing / Commidity managers in supplier selection process, including supplier qualification audit
Take charge in supplier development, supplier change, supplier phase-out programs
Take charge in supplier quality performance monitoring and improvement activities
Support in supplier quality complaints resolution as needed
Coach suppliers in quality management tools needed
Take charge in supplier cost of poor quality reduction via charge-back, quality improvement etc
Take charge in other supplier quality related improvement activities assigned by Supplier Quality Manager
Other work assigned by Supplier Quality Manager
Good product knowledge in PCBA ,welding products, electrical motor, wire harness etc
Good auditing skills
Good reporting & presentation skills
Good working attitude, responsible, proactive, diligent, pressure resistance, careful and quick thinking
Good learning capability / adaptability to new things
Good in English language skill - fluent in both written & spoken

Senior Supplier Quality Engineer Resume Examples & Samples

Early supplier involvement and new product introductions (including establishing supplier involvement in service & field feedback)
Supplier quality performance management from new product release to end-of-life
Field feedback and corrective actions
Good product knowledge in machined parts, PCB, welding products, motor, gas equipments
Ability of reading & reviewing mechanical or electrical drawings
Ability of using measurement tools (caliper, hi-pot testing machine etc.)
Good in English & Chinese language skill - fluent in both written & spoken
Good understanding & application of QC tools, 8D, DMAIC, SPC, FMEA, Control Plan, DOE
Very good capability of influencing people & strong personality & team player
Rich experience in improvement project management, lean or GB is preferred

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelor Degree in an Engineering discipline is required (Mechanical preferred)
5 or more years of experience working in quality (prefer supplier quality)
7 of more years of experience and knowledge about the APQP Toolbox, ISO/TS 16949 requirements, ISO/TS 16949 Technical Quality/Audit experience
Ability to evaluate supplier performances, trends, generate reports, identify supplier deficiencies and drive Root Cause Analysis (RCA) using the 8D methodology
Above average knowledge about the TS16949 system and related quality tools
Excellent English communication skills (both oral and written)
Ability to work across the organization and provide influence to achieve goals
Experience with machining and castings highly preferred
Intermediate skills/experience with MS Office (including MS Word & Excel)
Prior experience with ERP/MRP system (SAP preferred)
ASQ certified as a Certified Quality Engineer and/or Certified Supplier Quality Professional is a plus
Six Sigma Green or Black Belt preferred
Ability to travel up to 45% as needed during program launches
Relocation support available!

Senior Supplier Quality Engineer Resume Examples & Samples

Supplier Selection---Select the suitable supplier with jointed-effort of sourcing on aspects of quality, capability, pricing, delivery, environment, society regulation, etc. against customer requirements
Supplier Qualification---Implement the new supplier qualification thru the process of capability matching, supplier risk assessment, supplier self-assessment, onsite qualification audit, qualification database management
ECO/ECN/SCR implementation---Handle with ECO/ECN/SCR from customer, follow up the status in case that PPAP/FAI is required prior to production
Performs quality audits on suppliers to assure products and services meet International Organization for Standards (ISO) and regulatory standards Forms a good relationship with the purchasing engineer and the supplier system in order to maintain a strong support system and supplier relationships for the organization in which they work. Provides cross functional support to select, approve and develop suppliers to meet customer and business needs Ensures supplier selection, development, approval and rejection according to SJM vendor guidelines and requirements Drives full assessment for effectiveness of supplier process control plans, measures and activities Uses statistical techniques and professional independent judgment to analyze data for process improvement Develops and leads execution of process validations and tests; analyzes resulting data and document results (protocols/reports) Leads supplier process capability studies Constructs Design of Experiments to characterize supplier processes and/or determine root cause
Demonstrates advanced/thorough knowledge of the function and Flex business
Ability to read, analyze and interpret common scientific and technical journals
Demonstrates advanced operations, technical and people and/or process skills as well as customer (external and internal) relationship skills
Demonstrates expert knowledge of the function and a thorough understanding of Flex and related business
Demonstrates knowledge of multiple functional technologies/ processes, industries or functions and understanding of interdependencies of such processes at the site
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables

Senior Supplier Quality Engineer Resume Examples & Samples

Leads the assessment, qualification and monitoring of new and existing global manufacturers and suppliers of finished goods, sub-assemblies, ingredients and components based on associated risk. Provides internal and external audit support as necessary. This support includes conducting internal system audits of MKI manufacturing and distribution centers as well as Mary Kay International Subsidiaries. Provides support for audits of MKI and Mary Kay International Subsidiaries by external agencies (FDA, TDH, CFDA, etc.). Generates and tracks the supplier audit schedule, and performs audits to ensure quality and regulatory requirements are met while also meeting budget and timeline objectives. Reports audit results including corrective action plans when applicable. Serves as a corporate supplier quality technical contact/subject matter expert for Mary Kay, Inc. (MKI) and Mary Kay International Subsidiaries (Asia Pacific, European/Russian, Latin American, and North American regions). Collaborates with Regional supplier quality management teams to support region needs for local manufacturing and/or local sourcing while maintaining the Mary Kay Corporate Quality standards and with other internal departments to ensure supplier compliance with MKI policies. Manages proprietary and confidential information regarding supplier qualification status of Mary Kay’s suppliers
Develops and maintains effective supplier relationships. Proactively identifies, implements and monitors systems, policies, and procedures to help ensure that proper supplier quality management systems are maintained and the corporate Quality standards are met and consistently followed globally. Develops training programs and recommendations that promote awareness and understanding of MKI quality requirements, standards, procedures and processes. Regularly assesses processes to determine if requirements are being met. Identifies gaps between required and current supplier capabilities, and drives quality improvement plans and risk mitigation accordingly. Champions new approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices. Utilizes DMAIC approach and tools such as FMEA, SPC, Root Cause Analysis, 5S and Lean Manufacturing / Continuous Improvement concepts to drive continuous improvement in supplier performance, reduction in variability and achievement of process control. Works with suppliers on the design and execution of experiments for process optimization. Ensures that quality inspection plans for purchased items are appropriate. Drive supplier actions to verify product and process quality at their locations and evaluates the supplier for reduced incoming sampling and inspection activities at Mary Kay owned facilities. Manages additional special projects related to these objectives as required
Develops quality plans and provides quality support for new product introduction at external suppliers. Performs supplier capability audits, quality audits, certification and startup issue resolution. Analyzes engineering specifications, design changes and other data to plan support activities from conceptual stage through the production launch of the product. Assists in the development of DFMEAs, PFMEAs, control plans and PPAP where required. Participates in risk management activities to identify, design and process risks and ensure mitigation in compliance with MKI procedures. Serving as the Quality liaison to Procurement, defines the quality-related supplier selection criteria, develops and maintains supplier quality agreements and scorecards, and reviews periodically supplier quality and business updates. Must remain knowledgeable about significant global regulatory changes that could affect the supplier and compliance quality
As a corporate supplier quality technical contact/subject matter expert, investigates internal and external failures in supplier quality and compliance quality systems to determine cause and works with the supplier to resolve issues. Responsible for oversight of effective CAPA process for all suppliers. Partners with cross-functional team (including Quality, R&D, Manufacturing Operations, Purchasing, Engineering, and Legal) to request input to aid in investigation, root cause analysis, and development and implementation of corrective action plans. Leads investigation and root cause analysis on product quality issues and applies appropriate control plans to achieve issue containment. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Develops and recommends viable solutions in response to both immediate issue resolution and long term systemic resolution and prevention of recurrence. Recommends policy and procedure changes as necessary, and assures changes in process or material specifications are completed in accordance with change control procedures. Verifies that system changes at the supplier are implemented and monitors the systems over time to verify improvement. In collaboration with cross-functional team, assesses gaps in the consistent execution of supplier quality standards to formulate recommendations for immediate action, and systemic resolution and prevention of recurrence. Monitors and analyzes supplier quality performance metrics (KPIs) and Cost of Poor Quality Data to identify recurring trends and drives improvement actions to reduce internal and external failure costs
Must have a good understanding of advanced quality principles, audit protocol, inspection procedures and FDA and GMP regulations. Must be familiar with compliance requirements for over the counter (OTC) products and similar globally. A knowledge and understanding of multiple manufacturing processes/formulations, international requirements and bilingual skills are beneficial
Must have a strong knowledge of quality improvement methodologies and related statistical tools and techniques
Must have the ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts
Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity. Solutions should be imaginative, thorough and practicable
Must have excellent oral and written communication skills in order to interact with various levels of personnel from different cultures both within and outside the Company
Must have the ability to perform duties under very general direction and independently perform assignments with only general criteria for expected results. Must have excellent project management skills in order to perform and prioritize a wide variety of activities simultaneously
Requires travel up to 30%

Senior Supplier Quality Engineer Resume Examples & Samples

Establish Incoming Inspection Requirements, IIR, in the Incoming System SAP
Train Incoming Inspection Inspectors to perform new or revised IIR activities.-
Issue NCMR or ANCMR as necessary for Non-Conforming Materials-
Timely and Effectively Disposition non-conforming materials at Incoming or returned from the Production Line and conduct MRBs (Materials Review Boards) as necessary involving the required engineering disciplines
Perform and/or coordinate FAI (First Article Inspection) for new Material Part Numbers. Issue to Suppliers NCMRs, (Non-Conforming Material Reports), request Corrective Actions and manage Supplier Corrective Actions Effectiveness and Responsiveness.-
Coordinate with Supplier Quality Field Engineers follow up activities on Corrective Actions for detected Incoming/Factory Material Rejections and Product/Process/System Audit Findings
Identify Incoming Inspection Parts which inspection activities can be reduced or eliminated
Improve Supplier Quality relying on data, facts and actions
Prepare Monthly Supplier/Materials "Quality Deep Dives", (Trends, Paretos and Specific Improvement Actions) to drive focused Supplier Quality Improvements activities Work with Product Engineering and Suppliers to optimize Honeywell or Suppliers Specifications to improve materials manufacturability and reduce rejection rates.-
Establish as necessary Supplier Quality Improvement Plans/Programs to accelerate Supplier/Materials Quality Improvements
Reduce Cost and Cycle Time of Incoming Inspection Activities
Conduct periodic Supplier Quality Improvement Program/Activities Reviews
Be a member of the Material Change Control Board and be an active Reviewer and Approver of Material Change Orders affecting the materials/suppliers under his/her responsibility
Provide technical leadership in the change review process with Suppliers prior effective date of change implementation
Participate as a member or leader in Site Commodity Quality Improvement Management Teams
Participate as necessary in Site Cross Functional Quality Improvement Teams

Senior Supplier Quality Engineer Resume Examples & Samples

Monitor supplier performance (KPI’s) through regular communication and frequent reporting and follow-up on process and product changes and/or nonconformance’s
Work closely with the Purchasing Team to qualify suppliers and perform initial and periodic follow-up assessments/audits
Develop and improve the Supplier Quality Management including ECOs, NCRs, SPC (statistical process control)
Support the suppliers to ensure that products and processes comply with the relevant requirement
Perform root cause analysis and corrective action for supplier process and product related non-conformances
In a timely manner, analyze failure, corrective, and preventive action to respond to supplier concerns
Review and approves supplier records including but not exclusive to: contracts, quality plans, change requests, CAPAs, NCRs, verification and validation protocols and reports
Support Quality Management Team in establishing, implementing, and maintaining the quality management system for ISO 9001:2015 and ISO 13485:2016
Mechanics Engineering, B.S. Engineering/Operations Management, Biological Sciences or equivalent
Several years’ experience in Supplier Quality and Quality Management
Fluency in English and German (minimum Level C1/C2)
Be able to effectively communicate with suppliers as well as align with the internal function representatives (e.g. R&D, Manufacturing Process Engineering and Purchasing)
Knowledge and understanding of critical design attributes and auditing/surveying capabilities
Strong Communication Skills (both oral and written) will be necessary to support the assignment
Must be a team player with strong interpersonal skills
Ability to take direction quickly and continue to work with minimal supervision
Must be able to read and interpret engineering drawings
Previous experience in Supplier Quality Management (ISO 9001) and SPC
Position will require travel (domestic and international)

Senior Supplier Quality Engineer Resume Examples & Samples

Provide supporting documentation for changes to the Approved Vendor List
Perform research and provide supporting information for quarterly and annual Approved Vendor List Reviews and supplier performance monitoring
Plan and conduct audits of suppliers to assess compliance with Boston Scientific requirements, including audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions
Assess supplier capabilities through onsite visits, technical discussions and quality system audits
Communicate quality issues to suppliers and customers as needed and provide assistance in developing corrective actions
Review and approve supplier corrective action plans and verification of effectiveness documentation
Coordinate the evaluation of proposed changes at suppliers
Facilitate the evaluation of new and revised services to determine the supplier's ability to meet specifications
Work with site and/or global teams to improve BSC's supplier quality processes
Provide guidance in applying supplier quality system requirements
Facilitate and lead Service Commodity team focused on Quality, Cost, and Capabilities globally
BS degree in Engineering or Technical field with 5-8 years of relevant experience
Lead auditing or quality systems experience (ISO 13485, 17025, or similar)
Technical laboratory or regulated operational background preferred
Sterilization and/or Calibration experience preferred
Self-Starter as a Sr. level engineer covering the east coast region for a global team
Travel for role approximately from 20-25% of time
Leadership experience on a materials or service commodity team
Experience in process improvement projects (DMAIC or other)
Ability to influence cross functional global teams spanning quality, operations, and sourcing

Senior Supplier Quality Engineer Resume Examples & Samples

Communication in a clear and concise manner
Manufacturing plant and Production process experience
Ability to understand drawings and technical specifications

Senior Supplier Quality Engineer Resume Examples & Samples

Degree in Electrical Engineering is highly preferred
5+ years of experience in supplier quality or engineering
Medical Device experience
Good working knowledge of statistics
Ability to work cross-functionally

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelor of Science degree in Engineering (Mechanical, Biomedical, or Materials preferred) with 4+ years of related professional work experience
Experience in medical device industry is preferred
Experience in a regulated manufacturing environment and troubleshooting product and manufacturing processes
Knowledge of quality tools, risk analysis, statistics
Computer literacy, use of word processing, Excel spreadsheets
Knowledge of Quality System requirements, ISO and FDA requirements (preferred)

Senior Supplier Quality Engineer Resume Examples & Samples

Lead or participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements
Work with suppliers/contract manufacturers to drive systematic approaches to medical device quality issues
Facilitate supplier improvement/corrective action through the following activities
Work with the supplier/contract manufacturer base to drive corrective/preventative action based on feedback from incoming inspection, supplier/contract manufacture internal quality metrics and customer complaints
Lead and work with production areas to implement quality-based improvements to current products and manufacturing processes
Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented
Review/prepare test plans and reports (qualification, validation) for change and improvement activities (transfers, supplier certifications, material/sub-supplier changes and supplier performed special processes)
Provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure resolution to all issues raised during testing/qualification
Develop and implement systems and processes for supplier/contract manufacturer management that are in compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines
Supports Corporate and external (FDA, TuV, KEMA, PMDA etc.) quality and compliance audits of the supplier/contract manufacturer quality system
Provide input into the design, reliability, and manufacturability of new products/devices to Medtronic R&D based on process capability of supplier/contract manufacturer
Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements
Support sustaining engineering projects that may involve manufacturing transfers, label/IFU updates, sub-supplier qualification and design qualification (released to production)
Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities
As appropriate, institute appropriate root cause corrective actions relating to customer complaints and production defects and monitors for desired results
Partner with Sourcing Engineering to develop and implement strategic and tactical initiatives and execute to support the CM/OEM Value Stream
4+ years engineering or quality experience
Experience with and understanding of statistical tools
PFMEA and risk based decision experience
Ability to work in a team/cohesive environment
Experience working in a manufacturing assembly or machining and molding (dip/injection) environment
Quality System integration
2+ years experience in the medical industry or related field, with emphasis in Quality
3-5 years Contract Manufacturing / OEM experience in multiple areas, including manufacturing and process controls
Master's degree in science or Engineering
While performing the duties of this job, the employee must be able to stand/walk/sit up to 8 hours a day
Must also have the ability/vision to read written and published quality documents and to observe operations

Senior Supplier Quality Engineer Resume Examples & Samples

Support supplier investigations to ensure root causes are determined and appropriate corrective actions are implemented to prevent repeat non-conformances
Lead effective Supplier Corrective Action and Preventative Action (CAPA) investigations
Determine adequacy of part acceptance activities and make necessary improvements
Communicates effectively within the project teams as well as Sr. Leadership through project reviews and status reports including preparing reports and quality system metrics
Conduct supplier audits to determine effectiveness of QMS and Process Control (both qualification and ongoing maintenance audits)
Assist in the qualification and disqualification of suppliers, initiate improvement plans when necessary
Develop and implement Quality Plans with critical suppliers
Monitor supplier processes and performance
Drive continuous improvements of the quality program
Minimum of 6 years work experience in Quality Assurance within a regulated industry (21 CFR 820, 21 CFR 211, ISO13485, AS9100, TS16949) is preferred
Minimum 3 years of experience in Supplier Quality or related field
Leadership, facilitation and communication skills
Knowledge of quality tools such as PPAP, statistics, SPC, PFMEAs, Control Plans, 8D, Change Management, Process Control Audits
Ability to work independently across multiple organizations
Good report writing and reviewing skills
Experience with stamped metals, machining, forgings, castings, plastics, sheet metal
Ability to travel upwards of 30% domestic and international
Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing-GD&T), and/or electrical and fluidic schematics
ASQ certification(s)
Operational Excellence/Six Sigma/Lean training or certifications
Experience using SAP or Oracle and Sparta Trackwise helpful
Knowledge of various quality systems

Senior Supplier Quality Engineer B-chassis Resume Examples & Samples

Support supplier APQP and PPAP activities to ensure all deliverables are being fulfilled
Be an effective liaison between the supplier and the extended FCA team
4 1/2+ years of work experience in Quality, Supplier Quality, Engineering, Manufacturing or a related field
Ability to travel up to 40% within the NAFTA region
Internship experience within Supplier Quality, Engineering, or a related field

Senior Supplier Quality Engineer Resume Examples & Samples

Perform supplier quality systems and process audits and lead Supplier improvement/development programs
Initiate and follow-up on corrective actions and verify effectiveness on-site
7+ or more years of work experience in Supplier Quality, Quality, Engineering, Manufacturing, or a related field

Senior Supplier Quality Engineer Resume Examples & Samples

Lead activities within the Commodity Manager to improve supplier quality, delivery, and performance for the assigned GBE’s products and suppliers
Lead PPAP qualification activities associated with new parts as part of NPI projects, and re-qualify parts as part of supplier transition projects
Utilize standard Honeywell processes to audit and approve new suppliers associated with the assigned GBE’s products and business
Liaison effectively with Commodity Managers, Program Managers…etc. on supporting High growth Region transition projects from Supplier Quality Perspective
At least 5 years work experience and strong knowledge related to the manufacturing, design, and good experience on Mechanical Commodities and Electronics Commodities, OEM/ODM Supplier Quality management and development experience preferred
Bilingual –Fluent English is required

Senior Supplier Quality Engineer Resume Examples & Samples

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Demonstrated ability to execute
Technical and business process problem solver
Critical thinking, troubleshooting and problem solving ability

100

Senior Supplier Quality Engineer Resume Examples & Samples

5 years SQE or QA experience minimum
Good at quality tool ( CAR, 5 WHY . QC 7 method …)
Preferred with casting &machining experience
Good English skill
Hardworking

101

Senior Supplier Quality Engineer Resume Examples & Samples

Participate in improvement activities to address chronic poor performing suppliers through QIP and “Top focus” processes
Bachelor’s degree in Quality, Engineering or related field
7 + years experience required in a Quality assurance/Engineering discipline preferably in Supplier/OEM environment
ASQC Certified Quality Auditor or ASQ Certified Quality Engineer preferred
Must have excellent communication and organizational skills
Must have knowledge of computer programs: MS Excel and MS PowerPoint

102

Senior Supplier Quality Engineer Resume Examples & Samples

Independently Produces and completes Supplier Quality Engineering related activities and documentation
Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met
Qualifies and sustains sub-processes of suppliers, including performing process validations for critical supplier processes impacting part quality
Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (MQA/APQP / PPAP), and SQ audit results
Executes SCAR management, effective and timely closure and Review/risk assessment of QN's and their escalation to SCARs where needed
Independently works to deploy common approaches and working methods to drive ‘’One Philips’’ towards Supply Base in the assigned BG or Market
Bachelor’s degree in an engineering or science discipline, or equivalent experience
Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course is preferred
8-10 years of total industry experience 4+ years of related experience in a medical device or regulated industry

103

Senior Supplier Quality Engineer Resume Examples & Samples

The Senior Quality Engineer will monitor quality performance of suppliers and external manufacturer’s, establish inspection and test methods for assigned product lines manufactured at suppliers, participate in technical assessments & quality system audits of suppliers to identify potential areas of risks, process variability and address root causes
Using Six Sigma methodology, is able to perform process variability studies, Risk analysis, test method variability and establish sampling plans
The Senior Quality Engineer will lead or support teams to investigate quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA
The Senior Quality Engineer will provide support to develop and maintain good documentation to support the Validation Process, specifications, manufacturing and test procedures
The Senior Quality Engineer will participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements
Participates in preparation of Process/Design Failure Mode and Effects Analysis ( PFMEA / DFMEA)
The Senior Quality Engineer will participate in new product development team activities in the development and qualification of suppliers

104

Senior Supplier Quality Engineer Resume Examples & Samples

Be able to manage projects related to supplier quality and Supplier relationships to optimize performance at Supplier locations, Supply Centers and other operational affiliates. Responsible for Supplier Quality deliverables in NPD and LCE environments
Demonstrate understanding of Medical Device operations, V&V, ISO standards and quality and regulatory requirements and fundamental knowledge of various manufacturing processes such as injecting molding, casting and electronic assemblies
Have an advanced technical understanding of engineering principles related to medical device manufacturing
Form partnerships with Suppliers and Supply Center leadership to drive accountability in manufacturing processes, externally and internally
Identify supplier related problems & opportunities. Perform root cause analysis and drives resolution
Lead and monitor process validations (IQ,OQ,PQ) at supplier sites
Perform supplier Audits including, Auditing Planning, report writing and corrective action follow-up
Be comfortable with Failure Analysis Methodologies to drive Supplier Corrective actions
Bachelor’s degree in Engineering or another technical field
4+ years’ experience, including working Knowledge and application of engineering and scientific concepts in selected technical discipline
Basic knowledge of other technical disciplines
Applies basic tools, methodologies and technologies, including Statistics
Defined requirements for simple designs and material selection
Working knowledge and proven skills of PC computer operating systems including MS Office applications
This position will require ability to travel for up to 25% of time

105

Senior Supplier Quality Engineer Resume Examples & Samples

Four (4) year BS Engineering Degree (prefer major in Industrial, Mechanical or Electrical Engineering)
Proficiency in Data Analysis (Minitab, EXCEL, etc.)
Strong project management skills. (PMP)
Position will require some travel (20%, possibly international)
Prior Supplier Quality experience in manufacturing an analytic approach to problem solving

106

Senior Supplier Quality Engineer Resume Examples & Samples

Familiar with ISO standards, ISO 13485 is preferred
Good problem solving skills, Familiar with skill of APQP and 8D and SPC quality tools, capable for supplier continue improvement
Good communication capability and cross-function team work
Good English and Chinese Language is a MUST

107

Senior Supplier Quality Engineer Resume Examples & Samples

Ensures the annual definition of the quality improvement plan (QIP) based on business needs and timely implementation
Supports on-site/off-site supplier quality development including coordination /management of required internal/external resources
Manages the early involvement of suppliers in new product development and product/component improvement. Leads quality system audits
Coaches and manages the SQE team ensuring the competences and capabilities are in line with the business needs. Deploys and follows-up on the Supplier Quality Related KPI’s towards the supplier
Ensures the assigned supply base meets the Philips sustainability requirements. Ensures the timely and correct GSRS data-input. Participates in the Supplier Selection process for the quality aspects
Sets supplier quality aspects for new / improved products ensuring a.o. manufacturability aspects at suppliers (improve supplied quality)
Education: Bachelor’s degree in an engineering or science discipline, Current auditor certification with a recognized Accreditation body such as ISO-9001:2015 / ISO-13485, etc
Experience: More than 8 years of total industry experience (automotive industry is most desirable, then aerospace, then medical), with 4+ years of related experience in a medical device or regulated industry in supplier quality engineering function is a must
Very strong knowledge in application / deployment of APQP / PPAP process at supplier level for new product introduction at supplier level.-Must
Working knowledge of appropriate global medical device regulations, requirements and standards is a plus, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001
Strong knowledge of mfg. Operations and supplier quality development process and control methods; CtQ definition, DfSS, SPC
Good leadership and cross-functions coordination skill
Fluent in English and Chinese Langauge is a MUST

108

Senior Supplier Quality Engineer Resume Examples & Samples

5-7 years experiences in mfg / enterprise environment, familiar with Sheet metal , machining, stamping , coating process control
Familiar with APQP, PPAP ,supplier audit ,8D, MSA
Good English communication skills on read/writing and oral
Strong team worker and self-motivated with good temperament

109

Senior Supplier Quality Engineer Resume Examples & Samples

Proactively lead and address all supplier related quality issues including problem solving with the suppliers
Conduct detailed drawing and specification reviews with suppliers prior to outsourcing products and awarding business and supplier APQP reviews using cross-functional teams for all outsourced products prior to approving PPAP
Lead PPAP process of new and modified components
Assess supplier's competence/limitations with respect to measurement, testing and inspection systems ensuring acceptable gage correlation prior to PPAP
Manage supplier corrective actions, ensuring thorough root cause analysis
Provide feedback to production, manufacturing, quality regarding supplier open quality issues
Organize incoming inspection process (including Control plan, Trouble shooting)
Initiate and manage sort process of defective component (including cost analysis)
Perform annual on-site supplier process review
Initiate and lead supplier chargeback process of defective material
Taking a part/lead process audits at supplier locations
WISPER system maintenance
Bachelor’s degree in engineering, technical or other approved discipline
Three years minimum manufacturing or quality experience with a knowledge of blueprint reading, statistical methods, problem solving, industry quality standards, and continuous improvement tools
Knowledge of Lean Manufacturing techniques and processes
Knowledge of automotive quality standards and tools including APQP, PPAP, FMEA, MSA, 8Ds, SPC
Good written and verbal communication skills in English
Measurement methodology knowledge
Interpersonal and communication skills
Technical report writing skills

110

Senior Supplier Quality Engineer Resume Examples & Samples

Track the supplier’s performance indicators, based on their scorecards and rankings, to facilitate and develop the supply base’s ability to consistently meet or exceed our defined expectations
Routinely provide performance communication to the supply base and internal personnel to insure the proper use of suppliers based on performance
Develop the supplier’s ability to support Nordson’s Lean manufacturing principles and problem avoidance processes through the use of best in class quality, delivery and lead-time performance processes
Drive a systematic problem solving and process improvement approach utilizing Lean Six Sigma principles
Assure supplier’s corrective and preventive action plans are developed and executed in compliance with Nordson expectations. Report on the status of corrective actions, as required, to manufacturing, business group and executive management
Perform supplier on-site assessments and assistance visits for supplier selection, to improve supplier performance, and achieve Nordson’s balanced improvement objectives
Develop and implement (APQP) Advanced Product Quality Planning for new and existing purchase parts
Review supplier processes, collaborate with suppliers on process improvement, and value enhancement opportunities
Support and utilize the Strategic Group’s activities and direction on supplier development, risk management, reduction and consolidation
Support and coordinate with, the Strategic Group’s new product activities and direction to optimize the transition from new product development to production
All other duties as assigned
Bachelor’s degree in Engineering or other technical related field required
Minimum 5 years’ experience in quality engineering, related engineering field, or supply chain required
Working knowledge of quality control tools such as root cause analysis and basic SPC including CpK analysis
Strong written and verbal communication skills with the ability to communicate effectively at any level
Ability to work in a fast paced environment with competing priorities; ability to multi-task
Experience with Lean Manufacturing in a production environment, working knowledge of Six Sigma techniques, and ASQ certification preferred

111

Senior Supplier Quality Engineer Resume Examples & Samples

Analyze failure data from the factory and service to identify top failures and estimate improvement opportunities
Champion root cause analysis and implementation of corrective / preventative actions for top chronic (common cause) failures, working with Design engineers, Process engineers and Suppliers
Oversee disposition of First Piece Approval (FPA) / PPAP at the factory ensuring that all content meets Whirlpool standards
Travel to suppliers as required and perform process / quality assessments to ensure suppliers are capable to manufacture the components to support our needs
Establish specific short / long term quality goals for assigned suppliers and drive continuous improvement activities
Actively manage the assigned suppliers to ensure there are no regressions with the implementation of new parts or processes

112

Senior Supplier Quality Engineer Resume Examples & Samples

Developing and maintaining suppliers – executing Supplier Business Reviews, audit related activities and deep dive Technical Assessments at suppliers
Development/negotiation of Quality Agreements with suppliers
Changing the way, we do business – continuously improving our policies and procedures
The Supplier Quality Engineer will act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers
They will provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product
They will also provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements
A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science, Physical Science, or a related field is an asset. An advanced degree is preferred
An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred
Auditing experience is preferred. Strong root cause analysis skills are an asset. Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred
This position will be based in Cincinnati- OH, Juarez- MX, El Paso- TX, Guyanabo- PR or Albuquerque- NM and may require up to 25% of both international and domestic travel

113

Senior Supplier Quality Engineer Resume Examples & Samples

Perform supplier quality systems and process audits and lead supplier improvement/development programs
Work with engineering and supplier organizations to alleviate discrepancies in product specifications and evaluate cost reduction opportunities
Bachelor of Science in Mechanical Engineering or Electrical Engineering from an ABET accredited university; Bachelor's degree in Aerospace/Aeronautical, Biomedical/ Biomechanical /Bioengineering, Chemical, Materials, Metallurgical, or Mechatronics may also be considered

114

Senior Supplier Quality Engineer B-chassis Resume Examples & Samples

Participation in launch teams, lead and coordinate APQP/PPAP deliverables for purchased components within the supplier quality group
Present program status to Management and Executive Leadership both within and outside of Supplier Quality
7+ years of work experience in Quality, Supplier Quality, Engineering, Manufacturing or a related field

115

Senior Supplier Quality Engineer C-chassis Resume Examples & Samples

Perform supplier quality systems and process audits and lead Supplier Improvement/Development Programs
Work with Engineering and Supplier Organizations to alleviate discrepancies in product specifications and evaluate cost reduction opportunities
Bachelor of Science degree in Mechanical Engineering or Electrical Engineering from an ABET accredited University. A Bachelor's degree in Aerospace/Aeronautical, Biomedical/Biomechanical/Bioengineering, Chemical, Materials, Metallurgical, or Mechatronics may also be considered
A minimum of four and a half years of work experience in Supplier Quality, Quality, Engineering, Manufacturing, or a related field
Green Belt or Black Belt skills (Red X/Shainin)

116

Senior Supplier Quality Engineer Resume Examples & Samples

Support the evaluation and selection of global best-in-class suppliers/OEM through the application of appropriate tools and measurements
Develop a strong relationship with the Supplier/OEM
Prepare and negotiate Quality Agreements with suppliers/OEM
Apply process development and materials knowledge to component development and quality issues
Review supplier/OEM processes and equipment for optimum output, yield and process stability
Develop and implement supplier/OEM improvement programs, which may lead to certification of suppliers/components
Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes in Medtronic
Represent the organization as the primary supplier/OEM technical contact, at times requiring coordination between organizations
Review and approve changes to Medtronic specifications for purchased materials used in production and manage the supplier change execution process with the supplier
Develop and maintain controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals
Review supplier/OEM change requests and develop and implement appropriate strategies to qualify and support the change approval process
Analyze and identify trends from quality data and develop proactive measures with suppliers/OEM’s in support of continuous improvement
Work with Tier 1 Suppliers/OEM’s to ensure adequate controls exist on sub-tier suppliers and that appropriate monitoring is established by the Tier 1 suppliers
Maintain Medtronic supplier audit schedule and lead or participate in the audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements
Maintain Medtronic approved supplier files
Understand and operate to medical device regulatory guidelines (GMP, FDA, ISO13485, AIMD R-PAL) and company Quality System procedures
Function effectively as part of cross functional and at times cross organizational teams
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organization objectives
Develop strong partnering relationships with Supply Chain, R&D, Design Quality Assurance, and Manufacturing Engineering groups
Guide the successful completion of major programs and, as required, functions in a project leadership role
ASQ CQE certification
Graduate degree in technical discipline or MBA
ASQ Lead auditor certification
Manufacturing processes or R&D experience
Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls
Experience with supplier quality management

117

Senior Supplier Quality Engineer Resume Examples & Samples

Develops improvements to manufacturing processes and supports manufacturing engineering in process changes to ensure continued compliance
Develops test methods for incoming inspection and/or manufacturing
Oversees and participates in verification and validation activities, such as burn-in testing, data storage, systems validation, and equipment calibration/qualification
Develops and updates PFMEAs
Monitors and addresses nonconformance issues
Trends and reports manufacturing quality performance information and concerns
Manages and continually improves Quality System processes for manufacturing and supplier controls
Participates in evaluation and selection of suppliers and completes necessary selection and approval documentation
Participates in development and oversight of product acceptance criteria, and receiving/inspection processes
Develops and manages supplier External Quality Agreements
Maintains approved supplier list
Monitors supplier ISO certification status
Monitors supplier performance
Conducts supplier audits as needed
Establishes and oversees supplier control and development plans as needed
Establishes and oversees Supplier corrective actions as needed
Trends and reports supplier quality performance information and concerns
Manages and continually improves Quality System processes for supplier control
Conducts Root Cause Analysis for process and component failure modes
Applies critical thinking to recommend solutions to complex issues
Manages appropriate levels of interface with
4 year college degree
4 years of quality, reliability, or product development engineering experience in a medical device environment
Proficiency in statistical, quality and continuous improvement methods and tools
Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) certificate
Working knowledge of product risk management and supplier control regulations and standards for medical device manufacturers
Working knowledge of product development, process development, process validation, design of experiments, and protocol/report preparation
Knowledge of medical terminology, physiology and/or applicable disease states, therapies and technologies
Excellent verbal communication skills
Strong technical writing experience
Effective team member
Ability to effectively manage multiple projects and priorities
Ability to work with Microsoft Office applications

118

Senior Supplier Quality Engineer Resume Examples & Samples

Supplier Quality Management, Development and Supplier process improvement (65%)
Ensure suppliers Quality readiness for NPI and SOP for all product categories
Working with the supplier directly, create corrective action plans to address process failures
Review supplier manufacturing processes/yield, collaborate with suppliers on process improvement and value enhancement opportunities
Collect and maintain supplier performance metrics
Ensure that alignment and agreement is reached between Supplier/s Engineering and/or Manufacturing for Dyson drawing sign offs, taking in to account the suppliers capabilities to meet the requirements
Assist Procurement in conducting Supplier Audits, reviews assessments and categorizations of new and existing suppliers for selection and de-selection
Support corrective action process (10%)
Ensure that the Suppliers RCCA process meets minimum Dyson requirements and expectations
Investigate reported external quality issues that are believed to be purchased part or product driven and present findings at SEA Quality meetings
Perform, lead or coordinate root cause analysis on purchased part or product quality issues and work issue through containment phase of corrective action process
Support Supplier Qualification and Disqualification (25%)
Strong technical background in moulding/painting and Quality management

119

Senior Supplier Quality Engineer Resume Examples & Samples

Technical degree in engineering discipline or equivalent work experience with minimum 5 years experiences in supplier quality management
Must have a strong technical background in working with Packaging, or Plastic Molding and Metal Stamping suppliers
Or Must have a strong technical background in working with PCB & Electro-Mechanical suppliers
Quality system and Production process audit skill. Is able to create and manage quality improvement plans at supplier site
Technically incline and knows how to interpret drawings / diagrams. Able to read English drawings and specifications. Able to communicate through English e-mails and oral skill
Strong knowledge and experience in Process Capability Study (Cpk), Process Control Charts, Control Plan, PPAP, Inspection Plan, 8-D, APQP etc
Understanding of ISO9000, TS16949 and Lean Manufacturing, Six Sigma belt status a plus
Strong team player with good knowledge in team building, team leadership and brain-storming
Self-driven, result, and process oriented. Motivated to work effectively without direct supervision
Good computer skill in Excel, Power Point and Word. Strong analytical ability
Experience in supporting USA or European factories for sourcing from China, including the co-ordination with divisional commodity managers and product engineers in the USA or Europe, and supporting supplier discussions if required
Willing to travel. (Up to 40%)

120

Senior Supplier Quality Engineer Resume Examples & Samples

5 – 10 years’ experience in Supplier Quality and Quality Management
Previous experience in Supplier Quality Management (ISO 13485) and SPC
Lean Six Sigma Green or Black Belt certified highly preferred
Several years working experience with ISO 13485 preferred

121

Senior Supplier Quality Engineer Resume Examples & Samples

Bachelor degree, major in mechanical, material science is preferred with at least 5 years working experience for Supplier Quality Management
Fluent English in reading, verbal and written, Minima CET-4 required
Be familiar with TS-16949 quality management system & ISO14000 and use TS tools and QC tools, such as 8D, 6 Sigma, MSA, SPC, FMEA, APQP, PPAP, control plan, etc
Very good communication and coordination skill. Driving for achievement. Result oriented. Self-motivated, quick response & capable for people management
Experience in automotive industry and or familiar with automotive quality mindset/requirement and coordinate between different departments
Good computer skill of Word, Excel, PowerPoint, Outlook, Visio, etc. Familiar with SAP is preferred

122

Senior Supplier Quality Engineer Resume Examples & Samples

Provide training to other team members on root cause problem solving techniques
Provide training to other team members on effective SPC techniques
Identify advanced and more efficient inspection methods
Has appreciable latitude for unreviewed action or decisions
Usually works with general supervision, conferring with superiors on unusual matters
Possesses certifications in the quality field such as CQE / Six Sigma Green Belt
Excellent analytical skills
Quality Assurance knowledge and understanding
Quality Systems knowledge (QSR, ISO 13485)
Possesses strong understanding of core process methodologies and problem-solving techniques related to primary role
Possesses ability to generate and explain detailed proposals, guidelines, and procedures for the QA functions to departmental and/or non-departmental personnel
Drives for results through timely decision making and the ability to prioritize, plan and measure work
Uses direct persuasion to convince and influence others
Resolves conflicts and disputes by addressing multiple view points to develop a mutually satisfying outcome
Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization
Possesses the ability to interact with diverse internal customers in an effective manner
Communicates information verbally and in writing in the appropriate language and format according to the audience
B.S. / M.S. in an Engineering discipline
Minimum 3-5 years of related experience

123

Senior Supplier Quality Engineer Resume Examples & Samples

Direct and Maintain Supplier Management Program
Ensure all suppliers are properly qualified
Develop the Supplier audit schedule and ensure supplier audits are completed as scheduled. Timely follow-up on supplier quality issues
Maintain control of quality costs for the supplier management program including incoming sampling and personnel costs
Supervise, direct, and give guidance to Associate Supplier Quality Engineer
Ensure full compliance with policies, procedures, QSR and ISO
Assume responsibility for proper documentation and revision control to meet FDA and company established standards
Provide support on teams as required
Solve the manufacturing and Quality problems to support de manufacturing operation related with the supplier issues and responsible for follow up of the Quality improvements with them
Knowledge in sampling techniques, GMP’s and QA basics. Knowledge of QSR and ISO requirements strongly recommended drawing interpretations
Familiar with windows Operative Systems (EG, Excell, Word)
Good communications skills, dynamic, positive attitude with good interpersonal and organizational skills, proficient, ability to solve problems, responsible, ability to work under pressure
High level of leadership and capable of manage different projects at the same time
Able to communication both verbally and writing in English (Desirable)

124

Senior Supplier Quality Engineer Resume Examples & Samples

Lead Wafer Fab Direct Materials Supplier for continuously Quality improvement
Drive standardization of processes across multiple WW factories SQE/IQA (Material Verification, Supplier Assessments, Qualification, Audit and etc.)
Perform Supplier Performance evaluation and monitors the implementation of committed improvement actions
Develop and monitor new/existing suppliers to ensure quality objectives are achieved
Conduct wafer fab suppliers periodic quality reviews and audits to drive full compliance of quality requirements
Develop monitoring systems and drive systematic quality improvements at suppliers through bench marking and lessons learned fan-out
Partner with Global Commodity Managers in reducing cost of materials and components while maintaining a high sensitivity of quality
Develop processes to identify potential problems and improvements with design and new products specification
Drive and ensure Critical Direct Materials supplier with built-in quality from product development to mass production phases
Collaborate with manufacturing and R&D engineers to improve overall product quality by emphasizing defect prevention throughout the development process
Tracking, management and reporting for the assigned quality initiative programs
Passion for excellence with high integrity, commitment to quality, fluent in oral and written communications
Willingness to take frequent travel and work with suppliers for continuously quality improvement
Work with internal and external stakeholders to resolve quality issues that arise quickly and efficiently without compromising of quality and safety standards
To follow-up with suppliers on quality incidents problem investigations as well as corrective actions/Prevention actions implementation effectiveness to prevent reoccurrences
5-10 working years’ experience in engineering, quality, supply chain or equivalent
Semiconductor Wafer Fab Process/Manufacturing experience

125

Senior Supplier Quality Engineer Resume Examples & Samples

Supplier qualification and selection
Support of regular supplier audits
Technical higher education
Technical background from construction business (as advantage)
Familiarity in the finishing of the interiors (Home Depot)
Very good knowledge of English (necessary condition)
Experience in supplier management (as advantage)
Practical knowledge of quality tools used in the process of complaints
Risk anticipation
Analytic thinking, decision-making and problem solving skills

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Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

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Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

Senior Supplier Quality Engineer Resume Examples & Samples

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