Advanced Quality Engineer Resume Samples
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Advanced Quality Engineer Resume Samples
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OR
O Rolfson
Orion
Rolfson
915 Edythe Cape
New York
NY
+1 (555) 319 0951
915 Edythe Cape
New York
NY
Phone
p
+1 (555) 319 0951
Experience
Experience
Houston, TX
Advanced Quality Engineer
Houston, TX
Wolff-O'Connell
Houston, TX
Advanced Quality Engineer
- May evaluate the performance of one or more Q.C. inspectors and/or technicians based on pre-established performance parameters
- Support product development by establishing product datum strategy and dimensional management plan during concept and design phases
- Supports and adheres to policies, procedures, and operational guidelines related to established quality management system (TS 16949)
- Manage Open Issues lists and assigns action items resulting from Workshops and tracks items to closure
- Develop and maintain quality management plans from the prototype phase until serial production
- Identify opportunities for improvement and work towards implementation of such opportunities with cross functional TEams
- Develop initial control plans and containment plans for assembly processes. Participate in the development of the Control Plans (Quality Assurance System)
New York, NY
Ur-advanced Quality Engineer
New York, NY
Bechtelar, Abshire and Shields
New York, NY
Ur-advanced Quality Engineer
- Providing support for our ISO certification and handles customer complaints
- Providing testing support for Glass Bubbles, Chemical and the CPDC, including setting up new test methods, setting up and conducting MSA's, and specifying and setting up new equipment
- Involvement in Business Transformation/SAP implementation
- Establishing and cultivating a network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments
- Participating in project planning. Assists in establishing project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in suggesting and testing ideas. Conducts and leads inter-laboratory test method studies. Plans and leads quality system and process audits
- May occasionally train, counsel, and guide the technical and administrative work of others
- Initiating and completing technical activities leading to new or improved products, processes or systems
present
Boston, MA
Associate Advanced Quality Engineer
Boston, MA
Kuhic-Hartmann
present
Boston, MA
Associate Advanced Quality Engineer
present
- Assist AQE in development of the Past Problem History Roadmap
- Assist AQE in development of APQP documentation
- Assist AQE in the preparation and on-time delivery of new product Launch related Customer Production Part Approval Process (PPAP) packages
- Support Measurement System Analysis (MSA) Launch plans for the Launch. Execute plans, collect data, and facilitate other gage related activity
- Perform other duties as assigned by Supervisor
- Assist with preparation of IMDS compliance documentation
- Execute Launch related inspection plans and containment plans as directed
Education
Education
Bachelor’s Degree in Biocompatibility Testing Required
Bachelor’s Degree in Biocompatibility Testing Required
Drexel University
Bachelor’s Degree in Biocompatibility Testing Required
Skills
Skills
- Strong quality mindset with working knowledge of statistical process control and process capability statistics
- Able to adapt well to change in assignments and priorities and able to adapt work methods in response to new information and changing conditions
- Both detail oriented and able to see big picture
- Strong Statistical Knowledge (SPC,DOE, CPk, etc.)
- High level of analytical ability; comprehensive understanding of Advanced Quality Planning and PPAP processes
- Good understanding of statistical methods, quality tools and methodologies
- Strong knowledge in Validation per FDA-QSR and ISO guidelines
- The following experiences/skill sets are highly desirable
- Excellent problem solving and analytical skills combined with impeccable business judgement
- 10) Demonstrated good written and verbal communication skills with ability to communicate effectively in Mandarin and English
15 Advanced Quality Engineer resume templates
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1
Advanced Quality Engineer Resume Examples & Samples
- Incorporates customer requirements into program AQP plan and assures requirements are cascaded to components AQP plan
- Develops a program specific quality plan on each new program
- Develops PDP (Quality) deliverables as associated with the PDP process
- Reports all Advance Quality Planning activities to customer periodically through APQP meetings
- Analyzes product quality problems and proposes solutions
- Develops and maintains statistics (X-Bar & R, Sigma, Pp/Ppk, Cp/Cpk, Gage R&R, etc) on all significant part and process characteristics
- Provides quality requirements for seat complete system
- Develops prototype control plan; collects and analyzes pilot build data
- Prepares pre-production sample report, submits to customer upon request
- Provides quality/warranty concerns to team by reviewing lessons learned, warranty performance, and ensures additions to the DFMEA
- Conducts surrogate process capability studies to support product dimensional capability
- Supports JIT plant by facilitating DFA and PFMEA development
- Supports JIT plant by assisting or facilitating PSO and PPAP activities (including PPAP to PCN changes after launch)
- Keeps good quality plan records and informs program team of timely execution
- Use e-business tool to communicate with program team and customer, and assure APQP/PDP compliance
- Coordinates APQP/PDP activities with Engineering, Manufacturing, Craftsmanship, SQA group, and the customer where appropriate
- Authorities as detailed in Standard Operating Procedure 8000
2
Advanced Quality Engineer Resume Examples & Samples
- Functions as the leader for Quality on Program Teams and ensures quality issues are resolved prior to launch of product (ensure mature quality at launch)
- Oversees and leads cross functional teams through the development of Process Flow Diagrams, Process Control Plans, and other Quality-related documentation
- Key participant on cross-functional team developing Design and Process FMEA’s
- Works with manufacturing plant and machine tool builders to develop capable manufacturing processes
- Ensures manufacturing process capability data is properly captured and reported via process capability statistics
- Ensures APQP and Quality-related GPMS process steps are being properly and thoroughly executed by program teams
- Ensures identification of key product and process characteristics and deploy necessary controls to ensure specifications are met in production
- Identifies and ensures best process and product practices are used across similar processes and products
- Works with cross-functional teams to solve technical issues
- Supports and adheres to policies, procedures, and operational guidelines related to established quality management system (TS 16949)
- Track and maintain data analysis of key metrics and performance data as it relates to APQP and GPMS process steps
- Strong leader with effective written and verbal communication skills who will drive processes and resolve issues
- Business or Technical Bachelor’s degree required
- Ability to travel domestically and internationally
- Minimum five (5) years of work experience required in Manufacturing/Quality environment
- CQE and/or Certified Six Sigma Black Belt is preferred
- High level of analytical ability; comprehensive understanding of Advanced Quality Planning and PPAP processes
- Demonstrated problem solving skills; i.e., 5 Why Analysis,
- Intermediate or Advanced knowledge of GD&T
- Organization & Time Management: Highly organized and able to manage multiple projects and associated tasks successfully
3
Advanced Quality Engineer Resume Examples & Samples
- Develop and obtain customer approved boundary samples and maintenance of the boundary samples throughout the production cycle
- Responsible for Management of the containment activities internal and external
- Review Warranty returns, follow up communications with customers and provide analysis of data as required
- 1-3 years experience in a manufacturing environment required
- Organization of documentation, records, time, priority setting and deadlines
4
Advanced Quality Engineer Resume Examples & Samples
- Functions as the leader for quality on program teams and ensures quality issues are resolved prior to launch of product (ensure mature quality at launch)
- Oversees and leads cross functional teams through the development of process flow diagrams, process control plans, and other quality-related documentation
- Key participant on cross-functional team developing design and process FMEA’s
- Ensures APQP and quality-related GPMS process steps are being properly and thoroughly executed by program teams
- Minimum five (5) years of work experience required in manufacturing/quality environment
- Business or Engineering Bachelor’s degree required
5
Advanced Quality Engineer Resume Examples & Samples
- Take the lead for PPAP and launch of all programs, engineering changes
- Own and drive process capability – CP/CPK on all developing programs (SPC, CM and in process gauge development Design, Quote, Procurement, Validation)
- Track development to meet program milestones
- Review component drawings and understand the application requirements for each component with dimensional studies on finished goods with road maps as required
- Effective launch transition to production
- PDP and Business Protocol Adherence, PDP documents to be completed as per program milestones and evidence provided for files
- Ensure best practice is followed throughout the Design process
- Ensure customer representation / resources are in place for launch readiness
- Analyse, troubleshoot and follow up on internal and customer quality issues
- Meet all commitments – confront and elevate issues in a timely manner
- Provide technical and administrative support at needed
- Implement strategies to support lean manufacturing principles and continuous improvement
- Perform any other ad hoc duties as required
- Bachelor's Degree in Quality, Engineering, Manufacturing Engineering, Mechanical Engineering or equivalent level of experience.Understanding of APQP Gate Review development process
- Understanding of FMEA and GD&T
- Understanding of manufacturing engineering with respect to one or more of these areas: die casting, metal forming, automated assembly, mechanisms, tooling fixtures and gauges
- Knowledge of SAP or similar production systems
- Strong understanding of Core Quality Tools (APQP, SPC, MSA, FMEA and PPAP), Control plans/Process Flows, Root Cause Analysis/Practical Problem solving
- Proficient in and learning the Business Operating Systems (TS16949, IMDS, QSI)
- Process knowledge (die castings, moulding, assembly(
- ISO/QS knowledge is a must
- Two to Five years of professional experience in a medium to high volume manufacturing environment preferred
- Results orientation with strong written and oral communication skills
- Strong computer proficiency with Microsoft Office, including Word, Excel, PowerPoint etc
- Able to work in a faced paced team environment
- Effective communication skills (written and verbal)
- Self-motivated, able to initiate and follow tasks through to completion
- Aptitude for working with numbers and a high degree of accuracy
- Motivate and assertive personality, willing to learn, seek opportunities for improvement
- Excellent problem solving and analytical skills combined with impeccable business judgement
- Flexible and able to provide support to a continuous operations environment
- Able and willing to travel and work extended hours based on customer demand and production schedule
- Able to adapt well to change in assignments and priorities and able to adapt work methods in response to new information and changing conditions
6
Senior Advanced Quality Engineer Resume Examples & Samples
- Perform data analysis, drive quantitative process improvements using six sigma tools
- Strong knowledge of Quality Management Systems like CMMI, ISO 9001:2008
- Experience in interpreting CMMI to different business needs
- Experience in conducting release Audit, Baseline audits and process compliance audits
- Estimation techniques and process performance models
- Process documentation in Eclipse Process Framework (EPF)
- Certified Quality Analyst, CSM, Green Belt Certified will be an added advantage
7
Advanced Quality Engineer Resume Examples & Samples
- Develop or assist in development of inspection and test methods and test method validations per internal procedures
- Develop Shelf Life test protocols and final report in support of expiration dating
- Support Pre-Concept Front End Product Innovation Process activities for new technologies
- Design and qualify inspection test methods and equipment
- Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, and ISO13485:2003 requirements
- Lead supplier part qualification activities including mold qualification and DOEs
- Support Process Transfers to the Production facilities
- Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances
- Perform DOEs and other statistical analyses to support product and process optimization or determine causes of variation
- Provide technical support to resolve quality problems in development, manufacturing or with suppliers as required
- Bachelor or Master of Science Degree in Engineering or Technical Sciences
- AQE II: With B.S., minimum of 3 years experience / with M.S., minimum 2 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
- Sr. AQE: With B.S., minimum of 5 years experience / with M.S., minimum 4 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
- Staff AQE: With B.S., minimum of 8 years experience / with M.S., minimum 6 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
- Experience in medical device including broad knowledge and use of disposables or implantables
- A high level of competence in statistical analysis techniques
- Prior experience with combination products and absorbable technologies a plus
- Determination of level will be based upon years of experience and demonstrated knowledge/skills
8
Advanced Quality Engineer Resume Examples & Samples
- Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field
- Leads basic investigations for product complaints and directs the activities required to assure the timely implementation and documentation of corrective action
- Provides support and assures QSR compliance in product and process validations and product and process transfers
- Monitors quality trends and participates in technical and statistical investigations on quality problems, reporting the results and recommendations in a timely manner
- Participates in the development of Process FMEAs
- Leads basic Quality Engineering Projects to improve Quality System and Procedures (e.g., defect analysis, control charts, data analysis, lead Quality and Continuous Improvement Projects)
- Develops or assists in the development of Process Validation documentation such as protocols and reports (IQ, OQ, PQ), executes qualifications, and performs statistical analysis as required
- Performs test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices
- Performs special projects and other duties as assigned
- Experience in Risk Management and transfer activities
- Relevant medical device experience
- Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 14971:2012
- Experience in Quality Engineering disciplines including product/process validation, applied statistics, and technical problem solving
- ASQ CQE certification preferred
- Experience with metrology and/or calibration instrumentation preferred
- Experience with combination products and absorbable technologies preferred
- Competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments
- Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project management skills
- Ability to manage multiple projects, communicate updates, and meet milestones in a timely fashion
9
Advanced Quality Engineer Team Leader Resume Examples & Samples
- 3-5 years’ experience in QA Production Processes within a manufacturing company, preferable experience working with R&D
- Proven experience working with suppliers and Contract-Manufacturers
- Familiar with Validation processes: IQ, OQ, PQ, MSA, GR&R
- Familiar with Office applications, ERP applications
- Mechanical or Electronics Engineer. Formal Quality Engineering education, CQE preferred
- Good understanding of ISO, familiar with FDA requirements preferred
- Familiar with the Quality tools, such as: FMEA, Lean manufacturing, Kaizen, DFM
- Excellent English as a working language – reading, writing and speaking
10
Advanced Quality Engineer Resume Examples & Samples
- Lead the implementation of quality systems and work closely with Design, Quality and Manufacturing Engineering personnel on product and process design during the development and introduction of new products and technologies
- Ensure that customer requirements are incorporated into product functional specifications and lead risk and failure analysis (FMECA/PFMEA) to ensure functional specification requirements are fully met during design validation
- Working from the design input requirements, functional specifications and risk analysis, develop necessary confidence levels and derive the resulting product and process validation and test plan. Interpret test results to predict product reliability
- Provide process validation support both internally and with vendors. Technically understand the process in question, develop and provide input to process validation protocols, coordinate inspections and analyze the results. Ensure agreement on inspection techniques, equipment and acceptance criteria. Work with the Project Team to achieve a robust validated process
- Lead the development of incoming attribute charts, in-process inspection procedures and final inspection plans. Minimise inspection costs while maintaining integrity and reliability of the product
- Design and implement new inspection technology, metrology equipment, functional gauges and fixtures to facilitate development, incoming and in-process inspection
- Will apply world class techniques (Six Sigma, Anova, Taguchi, SPC, Gauge R&R etc.) to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment
- Has the authority to order the cessation of all activities in relation to design and process validation and new product introduction. Also has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed
- Will develop supplier quality systems related to new product development and ensure their ability to deliver new products and components right first time. Will assist vendors in the resolving quality issues in relation to
- Audit findings
- Technical specifications
- Process validation
- Development of sampling plans
- Inspection techniques
- Coordinate the day-to-day inspection support for validation requirements and ensure completion of inspection requirements to ensure timely completion of project timelines
- Ensure the efficient and timely transfer of Quality systems knowledge to unit quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment. Ensure all appropriate documentation is in place prior to production start
- Act as statistics expert for capability studies. Teach statistical analysis and design of experiments techniques internally and externally across all functions
11
Advanced Quality Engineer Resume Examples & Samples
- Has some latitude for unreviewed action or decisions
- Usually works with minimum supervision, conferring with superiors on unusual matters
- Viewed as a team resource in the area of expertise
- These items pertain to software projects
- Bachelors Degree in science or engineering
- Minimum of 2-3 years experience in field of specialization
- Achieved a advanced (learning) level of industry knowledge
- Competent with Microsoft Office (Outlook, Excel, Word, etc.)
- Ability to solve problems in a high stress situation
- Eagerness to assist internal and external customers
12
Advanced Quality Engineer Resume Examples & Samples
- Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in multiple new product developments. Knows and applies the fundamental and some advanced concepts, practices and procedures of the advanced quality specialization
- Support the required stages defined in the design cycle ensuring compliance with the current design control and transfer regulations and policy
- Collect, interpret, and determine the root cause of failures
- May coordinate the activities of one or more Quality Control Inspectors and/or technicians
- May evaluate the performance of one or more Q.C. inspectors and/or technicians based on pre-established performance parameters
- Good interpersonal and team skills
- Innovation and resourcefulness
- Financial knowledge
- Excellent written/oral communication skills
- Demonstrated mechanical/electrical troubleshooting and problem solving skills
- Strong knowledge in Validation per FDA-QSR and ISO guidelines
- Strong Statistical Knowledge (SPC,DOE, CPk, etc.)
- Fully bilingual (English and Spanish)
- 3-5 year minimum in Quality Assurance or related functional area
- Knowledge of inspection methods in the design and production of electro-mechanical and/or mechanical equipment
- B.S. in engineering,engineering related discipline or equivalent experience
- Strong Statistical Knowledge (SPC, DOE, CPk, etc.)
13
Advanced Quality Engineer Resume Examples & Samples
- Work with the engineering group during product planning, design and development phases to assure that both economic and quality reliability goals are established and achieved
- Verify customer quality and reliability goals. Ensure feasibility
- Process & analyze data for Customer build events, run at rates and PPAP
- Translate quality/reliability goals into specific design inputs (work with engineering)
- Participate in the development of DFMEA’s and assignment of special product characteristics
- Establish test, inspection and evaluation strategies for all special product characteristics
- Ensure the incorporation of customer product performance requirements into a DVP and PVP and the associated test procedures. Participate in the development of DVP and PVP (work with engineering)
- Participate in the development of Process Flow Charts and the assignment of plant/process inspection points
- Act as primary quality interface with customer OEM on new advanced programs
- Develop initial control plans and containment plans for assembly processes. Participate in the development of the Control Plans (Quality Assurance System)
- Establish test, inspection and evaluation strategies to be employed for the various components and system
- During prototype, pilot and program launch, reviews customer complaints, analyzes customer returns, reviews plant responses regarding cause and recommended corrective action; maintains direct contact with customers on quality matters including handling and installation; and coordinates with sales and product engineering
- Ensure the review and appropriate corrective action to all DVP and PVP non-conformers
- Utilize the tools of APQP (PPAP, FMEA’s, control plans, capability studies, etc.)
- Participate/Ensure timeliness of corrective and preventive actions for internal and external quality concerns
- Familiarity with OEM systems, customer specifics and portals
- Ensure a safe working environment by observing safe work practices and by following all safety policies and procedures
- Bachelor’s Degree in Engineering or related field preferred; or equivalent combination of education and work experience
- Minimum 5 years of diversified experience in Q.A. systems, preferably in an automotive manufacturing environment and the launch of new programs
14
Advanced Quality Engineer Resume Examples & Samples
- Plan, organize and implement all kind of preventive/quality ensuring actions in development projects
- Collaboration in interdisciplinary and customer specific project teams to develop seating systems
- Define and implement quality requirements and targets in close cooperation with the customer and ensure them during the development process
- Develop and maintain quality management plans from the prototype phase until serial production
- Apply machine, process and measuring equipment capability studies
- Support the production plants in the implementation of product and process changes
- Universal degree or adequate education
- Trained in standards for quality management systems and application of quality management tools and techniques: APQP, FMEA, Inspection planning, SPC, DOE, QFD
- Good level of German and English in speaking and writing
- Unique free space for your ingenuity and consistent implementation of good ideas
- Direct project work for the world´s leading automakers
15
Regional Advanced Quality Engineer Resume Examples & Samples
- Lead, facilitate and execute advanced quality planning (AIAG APQP) activities in direct support of new product development (NPD) programs. Serve as core team member of new product development team and ensure that program goals, including quality and reliability, are met
- Develop APQP plans for NPD programs; ensure that resources are obtained as required from Operations, Engineering, Supply Chain, Suppliers and other related functions
- Participate in design reviews and assist design engineers in identifying product improvements, key product characteristics, necessary process controls and product validation tests
- Drive critical parameter management traceability from customer-focused, critical-to-quality requirements down to critical feature control plans supporting expected process capabilities
- Lead APQP and PPAP activities for both internal and external suppliers
- Assist project teams in the proper and consistent use design and process failure mode and effects analysis (FMEA) and resulting control plans so that high risk items are proactively identified and mitigated in the product and process development stages
- Lead resolution of quality related issues in newly launched products including active management of early launch containment activities. Develop and implement containment plans, root cause corrective actions and revised control methods as required
- Develop and manage relationships with program leaders, design teams, corporate and local quality personnel and others to ensure consistent application of advanced quality planning methods
- Support, maintain and enhance the Ingersoll Rand Quality Management System, assuring organizational adherence; promote system improvement via participation in product, process, and Quality System audits
- Leverage outside resources, best practices, internal consulting and past experience to ensure that organizational business object
- Bachelor’s Degree in Engineering, or BS plus equivalent engineering experience, and at least 5 years of product/process development, manufacturing and/or supply chain experience related to advanced quality planning required
- Requires ability to travel a minimum of approximately 25%
- Minimum of 5 years’ experience in manufacturing, design, quality or supply chain. Other relevant experience will be considered
- Professional certification (CPM, APICS, CQM, PE, etc.) is a plus
- Six-Sigma Green Belt trained or higher preferred
16
Advanced Quality Engineer Resume Examples & Samples
- Facilitates and conducts PFMEA Workshops
- Manage Open Issues lists and assigns action items resulting from Workshops and tracks items to closure
- Performs DFMEA to PFMEA walks on programs
- Supports JIT plants by facilitating PFMEA development
- Coordinates PFMEA activities with Engineering, Manufacturing, Quality, Divisions and the customer where appropriate
- Reviews and Incorporates customer requirements into program PFMEA and assures requirements are cascaded to components PFMEA
- Develops and maintains list of required error proofing (prevention and detection) for each operation
- Assess/Audit process phases at JIT and Component facilities as production equipment is installed
- Assess/Audit process phases at JIT and Component facilities at key program build milestones and specified intervals after launch, focusing on PFMEA linkage to Control Plan and JES
- Review Customer Concerns / complaints for read across into PFMEA
- Manage Open Issues lists and assigns action items resulting from PFMEA on-line process walks and tracks items to closure
- Generation of a Top 5 list and implement additional action’s. Living document that will be updated and reviewed regularly
- Maintains PFMEA template in Stature
- Maintains and updates master process map by operation PFMEA matrix
- Reviews past/current Read Across and PCA’s for input into PFMEA template
- Set up regular reviews and audits of the Read Across database for input into the PFMEA template
- Monitors and reviews Lessons Learned / Best Practices databases for input into the PFMEA template
- Monitors LRR and MAFACT audits (PFMEA sections) for feedback into PFMEA template and vice versa
- Monitors use of Read Across database and follows up with JIT and components plants on no responses
- Manage the Product Delivery Process PFMEA deliverables in accordance with documented work instructions
- Trains/coaches in FMEA methods and use of Stature software
- Prepares one-pager reports for program reviews
- Keeps good quality records and informs program team of timely execution
17
Advanced Quality Engineer Resume Examples & Samples
- Work with the engineering group during product planning PDP, design and development phases to assure that both economic and supplier quality reliability goals are established and achieved
- Ensure that customer requirements are addressed. Including the selection of
- Bachelor’s Degree in Engineering or related field preferred; or equivalent combination of education and 5 years work experience
- Demonstrated knowledge of OEM PPAP Requirements
- Advanced quality engineering activities require extensive knowledge of PFMEA, Control Plan, Containment Plans, GD&T, Check Fixtures, Gage R&R, APQP, PPAP, and AAR
- Minimum 5 years of diversified experience in statistics and Q.A. systems, preferably in an automotive manufacturing environment
- Demonstrated successful supplier PPAP to OEM end customer
18
Associate Advanced Quality Engineer Resume Examples & Samples
- Assist AQE in development of the Past Problem History Roadmap
- Assist AQE in development of APQP documentation
- Support Measurement System Analysis (MSA) Launch plans for the Launch. Execute plans, collect data, and facilitate other gage related activity
- Assist AQE in the preparation and on-time delivery of new product Launch related Customer Production Part Approval Process (PPAP) packages
- Assist AQE with any Launch related customer, internal and/or supplier quality corrective actions (8D’s)
- Facilitate delivery of Launch related components and product samples as needed to support Advanced Quality deliverables
- Participate in Appearance Approval activities as required
- Support execution of capability studies
- Assist with preparation of IMDS compliance documentation
- Attend and participate in System Simultaneous Development Team (SDT) meetings as required
- Support DV/PV builds, including verification that parts meet dimensional and functional requirements
- Execute Launch related inspection plans and containment plans as directed
- Support Internal Audits as required
- Perform other duties as assigned by Supervisor
- Bachelor's degree in Quality, Engineering, or Science related field
- Excellent problem solving aptitude. Experience preparing problem solving documents such as 8D’s is highly desirable
- Experience with ISO/QS/TS Quality Systems is highly desirable
- Knowledge of Advanced Quality Planning methods is highly desirable
- Experience with automotive quality requirements is highly desirable
- American Society for Quality certification, such as current CQT status, is highly desirable
- Experience working directly with customers and suppliers, particularly automotive related is highly desirable
- Ability to efficiently execute assigned tasks with minimal oversight
- Proficiency in use of a computer and common office software (i.e. Word, Excel, and PowerPoint)
19
Advanced Quality Engineer Resume Examples & Samples
- Facilitate and assure development of Design and Process Control Plans. These shall be based on customer requirements, Characteristic Matrix and FMEAs
- Facilitate and assure development of appropriate Measurement System Analysis (MSA) plan for the Launch. Identify appropriate statistical tools and techniques required for assessing process capability and verify all measuring devices are included on the Control Plan and PDFSS Scorecard
- Support DV/PV builds and verify that parts meet dimensional and functional requirements
- Experience with ISO/QS/TS Quality Systems is required. Lead Auditor certification is highly desirable
- Experience in Advanced Quality Planning including strong proficiency with the AIAG Advanced Quality Planning and Control Plan, FMEAs, PPAPs, MSA and Statistical Process Control (SPC) standards
- Knowledge and experience in Lean Manufacturing methods is highly desirable
- Proficient in use of a computer and common office software (i.e. Word, Excel, and PowerPoint)
- Strong interpersonal and communication skills, including ability to work in a self-directed environment
- Excellent problem solving skills, including experience preparing problem solving documents such as 8D’s
- American Society for Quality certification, such as current CQE status, is highly desirable
- Experience working directly with customers and suppliers, particularly automotive related
20
Advanced Quality Engineer Resume Examples & Samples
- Quality planning - and quality control activities from the concept to the series phase
- Coordination, adjust and tracking of the product validation
- To be the contact person for the Customer in all aspects of quality
- Definition and implementation of the quality requirements and quality objectives in close coordination with the Customer and their monitoring in the development process
- Organization and coordination of the initial sampling with the Customer
- Definition and preparation of component specifications
- Inspection equipment- and gage planning including their approval
- Support of manufacturing sites in the production start-up and implementation of product- and process changes
- Presenting of products and attend assembly workshops at Customer locations
- Initiation and monitoring of improvement- and modification actions
- Audit preparation and execution
21
Advanced Quality Engineer Resume Examples & Samples
- Develop, implement and audit the quality assurance and control activities as described in QCP
- Monitor and document customer's quality and reliability requirement into the appropriate document
- Develop and facilitate the test equipment maintenance and calibration for QC laboratories
- Assist process engineer and other function in solving product quality issues and customer complaint
- Keep plant management and other function informed on quality status
- Provide training to necessary disciplines in current philosophies and techniques necessary to assure the quality
- Provide quality information to 3M customer as required
22
Senior / Senior Advanced Quality Engineer Resume Examples & Samples
- Awareness of Non Destructive Examination (NDE) principles and practices, laser safety, and cryogenic safety requirements/experience desired
- American Society for Quality (ASQ) Certified Quality Engineer (CQE) also desirable
- BA/BS degree in a technical field (i.e., engineering, computer science, quality assurance, safety, or related)
- 7 or more years of directly related quality or engineering experience
- Ability to obtain/maintain NASA and IPC workmanship certifications (J-STD-100, NASA-STD- 8739.4 CCH, NASA-Std-8739.1A Polymeric Inspection), including vision test per NASA-STD-8739.6. Current holders of the certifications are strongly desired
23
Advanced Quality Engineer Resume Examples & Samples
- Lead/Participate/Approve Customer PPAP timing (Phased PPAP)
- Ensure all APQP requirements are known/tracked/adhered to using planned milestones
- Review Gov't Approvals required and develop Inspection Standard
- Leads Plant trials for Engineering changes, Tool Moves and New Program Launches
- Lead problem solving for applicable customer quality concerns (customer specific reports: 8D, 7 Step, 5 Phase, Is/Is Not, 6 Panel, etc.)
- Participate in Warranty reviews and analysis at customer centre
- Manages applicable new model launch field support to ensure effective containment and timely closure of issues
- Advanced Internal Activities
- Coordinate and participate in Internal/Supplier Drawing Reviews
- Prepare and complete Control Plans
- Prepare and complete component Receiving Inspection Matrix and Instructions
- Assist in Preparation and approval of Assembly Work Instructions
- Develop PV Plan (schedule) including reliability and confidence (R&C) requirements in accordance with Program timing
- Develop, implement and supervise launch containment system (LCS) Ph 1, 2 & 3 (Process and dimensional Evaluation)
- Participate in PFMEA review and team sign off
- Participate BOM review and sign off
- Lead EDR process- status/follow-up/resolution
- Facilitate supplier deviation requests (i.e. SREA’s, EDR’s) through closure with the supply base
- Initiate and participate in Campaign Prevention reviews
- Coordinate and participate in Early Supplier Involvement with Design and Purchasing
- Adhere to all Program Planning requirements and expectations
- Develop Customer attachment/contact point list
- Coordinate and ensure signoff / concurrence of control plan / attachment point checklist in conjunction with Mistake Proof Evaluation Procedure
- Review GD&T requirements (Finished Goods / Components)
- Prepare and present Launch QE Summary Report
- Develop Critical Characteristics Mapping
- Participate in Document Linkage Review
- Review lessons learned database
- Establish Supplier PPAP timing and review/approve on time prior to PV requirements (i.e. 1PP)
- Support pre-production builds
- Conduct Test Fixture Verification - Vehicle alignment, review and signoff to verify sequence, setup, etc
- Ensure proper level test parts are built and delivered to test lab
- Periodic review of in-process testing
- Post test set-up and results signoff
- TIR response and resolution
- Develop annual validation (RV) plan for designated programs
- Leads TIR investigation, prepares 8D report and ensure timely closure of issues (DV, PV, RV)
- Provide guidance to Quality Engineers
- Train members of Advanced Operations team in specific quality disciplines as required
- Participates in quality systems audits with customer and external auditors as required
- Minimum 5 years related experience in the automotive industry
- Sound CAD knowledge
- Strong GD&T Dimensioning Practices
- Well-developed communication, organizational, interpersonal and analytical abilities
24
Advanced Quality Engineer Resume Examples & Samples
- The AQE engineer collects, registers, support and evaluates quality deviations during LEANPD projects until start of the PPAP process
- He is responsible for all typical APQP Deliverables in LEANPD during the product and process design phase until the PPAP process starts, Facilitator
- Support the FMEA meetings to achieve the quality standard, structure and content
- The AQE engineers are creating prototype and pre launch control plans within the team during LEANPD
- AQE engineers are part of the project core team and being the Voice of the customer as well as the interface to other TE departments
- AQE engineers evaluates together with the core team members the customer specification, regarding technical quality requirements
- Checking the quality and content of the PPAP documentation
- AQE is responsible for supporting the “Lessons Learned” process during project start, during project development and in case of customer complaints to avoid re occurance for new developments. Part of that are also the Design Scorecards
- Managing technical information to the management and employees, e.g. trainings, seminars, lectures, software, quality standards
- Collaboration in introducing and training of new quality and engineering related software packages, Quality procedures and systems
- Training and servicing standards in APIS (FMEA), QS-STAT (capability), Lessons Learned Database, etc
- Supporting the implementation of general quality standards in Engineering departments
- Representing the company to the customer in quality related tasks during the LEANPD project
- AQE engineers are able to follow and lead customer 2nd party-audit’s as a part of a LEANPD project
- Support Safe Launch for critical projects to ensure 0 customer complaints before hand over the project to manufacturing site
- B.S. degree in electrical or mechanical engineering, or related field
- Up to 3 years
- Experience in Automotive and Quality related activities
- English Skills mandatory (verbal / written)
25
Advanced Quality Engineer Resume Examples & Samples
- Initiate, track and complete 8D analyses (internal and external)
- Identify opportunities for improvement and work towards implementation of such opportunities with cross functional TEams
- Lead internal & external problem solving activities for quality concerns on current products/production
- Make sure that APQP and PPAP processes are followed according to TE specifications
- Support quality function and deliverables across multiple product design/development project teams located in multiple regions
- Be able to read engineering drawings interpreting Geometric Tolerancing and develop the corresponding quality documentation
- Lead projects to ensure compliance with product specifications, customer requirements, and manufacturing process needs
- Insure all Quality aspects of the design/development projects are handled from the initial design of the project through production release and until exit of the safe launch phase
- Make sure product & design validations are planned and executed successfully prior to Start Of Production (SOP) and be a source of information and data for design of experiments (DOE) and capability studies
- Interface with customers, internal manufacturing sites and suppliers as required to address and resolve issues as they arise using 8D problem solving tools
- Host and lead customer audits as a part of the APQP/LEANPD project
- Essential Functions: FMEA method, FMEA moderation, standard automotive Quality tools in general (8D, PPAP, APQP etc…)
- Knowledge, Skills and Abilities: Automotive/Aerospace experience 5 years in both, customer quality and advance quality experience, LEAN and ISO/TS 16949
- Fluent in English language and strong interpersonal and communication skills
- Minimum Qualifications: Engineer level
26
Advanced Quality Engineer Resume Examples & Samples
- Responsibility of planning and observation of all relevant preventative quality aspects rgarding customer projects in accordance to relevant standards e.g. APQP (Advanced Product Quality Planning) and RGA (Reifegradabsicherung)
- Evaluation of measurement results and reports in respect of quality matters
- Realisation of preventative measures to improve or sustain product and process quality
- Evaluation of learning and best practice reviews during projects
- Where requested by our customer, provide assistance and support process audits
- First point of contact for all relevant quality queries or issues
- Collaboration with all relevant department and teams (Production/Manufacturing Quality, Reliability Quality along with Design and Production departments)
- Ensuring all correct project and product documentation (FMEA, EMPB and APQP) is in place
- Comprehensive quality and risk management using 8D, Fault Tree Analysis etc from concept to mass production
- Identification of potential optimisation and initiating amendments and improvement measures
- Degree (or equivalent) in Electrical/Electronic Engineering
- At least 3 years experience of working with Quality Management Systems (QMS) according to VDA and ISO/TS16949
- Established experience in Project Management of T1 OEM suppliers in the automotive industry ideally gained in the development of electric and electronic components, processes or systems
- Ability to communicate effectively in both English and German
- Customer focused with competence in providing solutions
27
Associate Advanced Quality Engineer Resume Examples & Samples
- FDA and international medical device regulations/standards/directive applicable to spinal implants and instruments (ISO 13485, ISO 14971, 21CFR820, 93/42/CE, cGMPs)
- Risk Management – Risk Analysis, Evaluation, and Control
- Advanced Quality tools such as Top-Down Risk Assessment, Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, Mistake Proofing/Poka Yoke
28
Senior Advanced Quality Engineer Resume Examples & Samples
- 8-10 years of directly related work experience in at least 4 of the following areas: Manufacturing/Assembly Operations, Advanced Product Quality Planning, Engineering Design, Design Manufacturing, Materials, Procurement, Six Sigma, Lean, and Program Management
- Experienced in using of process control tools such as FMEA, PMAP, and Cpk Analysis. Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to apply common sense understanding to carry out instructions in written, oral, or diagram form. Ability to deal with problems involving several abstract and concrete variables
- New Product Development Validation Testing experiences and knowledge
- Must be able to read and interpret complex engineering drawings and demonstrate a proficiency with geometrical dimensioning and tolerance
- Certified Green belt required - Lean Expert / Black Belt preferred
- A comprehensive knowledge of Advanced Product Quality Planning, Quality Assurance Engineering and practices applicable to the manufacture of aerospace products including regulatory, military, commercial, and industry/customer standards (i.e., ISO9001-2000, AS9100, TS16949, NIOSH, CSA etc), NPI testing is preferred
- Experience with high volume manufacturing and new product introduction including direct experience in launching new products and processes including NPI and Phase Gate required
- Strong persuasion and negotiation of critical issues, as well as demonstrated creativity, vision and mature judgment in anticipating / resolving complex issues
- Must be able to plan, organize, and implement multiple concurrent tasks and projects
- Must be able to routinely make decisions which effect immediate operations
- Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. assembly instructions, inspection procedures, capital proposals)
- Must be able to analyze and correct complex product and/or process issues using independent judgment
- Excellent analytical skills and promotes a problem solving work style
- Excellent interpersonal communications skills
- Demonstrated ability to operate small hand tool, inspection equipment
- Candidate must be fluent in English
- High level of interpersonal and communication skills is required to handle difficult or escalated situations during supplier strategy meetings
- Senior level of interpersonal and communication skills is required to handle difficult or escalated situations with suppliers
- Advanced problem solving and analytical skills to evaluate and identify appropriate alternative courses of action for definition and resolution of problems that are highly unusual and/or complex
29
Advanced Quality Engineer Resume Examples & Samples
- Customer’s representative to handle on requirement, claim and complaint of quality issue
- Response to the quality issue by submission the corrective action plan and 8D report to customer
- Follow up status of customer corrective action to ensure the taken action is maintained and effectiveness
- Collaborate with cross-functional team to improve the customer quality performance
- Work with QA technician to develop and implement training plan for each inspection area to ensure that quality control point, working standard are in place and maintain
- Establish, monitor, update and take action if the KPI result does not meet the criteria
- Participate and create the cost saving program i.e. Kaizen, Lean, Six sigma
- Bachelor’s Degree in Engineering or Science is required
- Minimum 5 years of quality related with automotive customer is required
- Good knowledge of ISO/TS 16949, ISO9001, ISO14001
- Solid organization, analytical and problem-solving skills by QC tools, 5 why , why- why, 8D
- Good communication skill and ability to work as a team player
- Leadership, Flexibility and follow up skill
- Proficiency in Microsoft office and Outlook
- Proficiency in the English language (Listening, Speaking, Reading, Writing)
- Knowledge of Lean, Six Sigma, Kaizen
30
Advanced Quality Engineer Resume Examples & Samples
- Engineer or Bachelor’s Degree in a technical field of study with a minimum of 5 years of experience in the field of supplier quality
- Knowledge of overall quality and quality systems
- Experience in using 8D methodology
- Working knowledge of ISO 9001. Experience with TS 16949 and it supporting tools (PPAP, FMEA, SPC, and APQP) is a plus
- Technical Knowledge of casting and machining process is a must!
- Continuous Improvement Mindset / Six Sigma is preferred
- Excellent communication skills and must be able to read and write English fluently
- This position requires travel up to 30% to 50% of the job. Travel will be in India, Asia and Europe
31
Ur-advanced Quality Engineer Resume Examples & Samples
- Providing support for our ISO certification and handles customer complaints
- Providing testing support for Glass Bubbles, Chemical and the CPDC, including setting up new test methods, setting up and conducting MSA's, and specifying and setting up new equipment
- Involvement in Business Transformation/SAP implementation
- Establishing and cultivating a network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments
- Participating in project planning. Assists in establishing project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in suggesting and testing ideas. Conducts and leads inter-laboratory test method studies. Plans and leads quality system and process audits
- Documenting results, observations and conclusions in technical notebooks (or approved electronic files) and prepares reports to communicate results to appropriate personnel
- May occasionally train, counsel, and guide the technical and administrative work of others
- Demonstrated ability to lead medium-sized teams is required. May lead projects over an extended period of time
- Initiating and completing technical activities leading to new or improved products, processes or systems
- Willingness to be on-call
- Currently possess or in the final year of Bachelor’s degree or higher from an accredited institution
- Experience in quality engineering, chemical product development, analytical laboratory, or chemical manufacturing engineering
- CQE, CQM
- Experience in quality systems such as Quality Manuals, ISO-9000, MSA, metrology, calibration, audits; demonstrated proficiency in the use of basic statistical tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability; MES, QPID/DPQ, MDI, Cert II, Minitab
- Skills include…Interacts with, laboratory, manufacturing, product development functions as needed to carry out assignments. Is required to cross functional boundaries and interface with these business disciplines in a significant manner. Provides consulting of a quality/statistical nature
- BT/SAP
- 3M Experience
32
Advanced Quality Engineer Resume Examples & Samples
- Conduct failure analysis on field/line returns to identify root cause and recommend corrective actions
- Lead Advanced Product Quality Plan (APQP) projects on new product and process introductions
- Support engineering and plant quality teams on DFMEA / PFMEA development
- Proactively seek out quality improvements for new and existing products
- Gather and analyze process data to drive continuous improvement and cost reduction efforts
- Work with Nidec Corporate Quality team to support implementation of Global Quality initiatives
- Support Nidec Procurement teams with auditing and evaluation of new or existing suppliers
- Develop Reliability test plans for new or existing products
33
Advanced Quality Engineer Resume Examples & Samples
- Establish a robust feedback machan for customer satisfaction data
- Seek opportunities for continuous improvement through the application of lean manufacturing techniques
- Establish a robust corrective process throughout the product delivery process
- Be responsible for site safety, health, security and emergency systems awareness
- Employees should strictly abide the EHS rules and regulations and behavior guide line in the plant; wear PPE in right way; actively participate in EHS training; do housekeeping at work; report accidents and unsafe issues immediately, join the accident disposal. Specific presentation can be reached in TMS system and individual job description
- Any other tasks assigned by supervisor
- Ensure TRIR & GSSF to reach yearly target
- Bachelor's Degree or equivalent in Engineering
- Familiar with TS16949 and ISO14001, Knowledge of Quality Systems
- Preventative attitude and quick response
- Highly focused on results and objectives
- Knowledge of MSDS
- Coaching and Leadership skills
34
Advanced Quality Engineer Resume Examples & Samples
- To support CFTs according to Dura’s Global APQP process
- Ensure that APQP deliverables are completed on time and per the requirements of the quality management system
- Attend Project Team meetings for all assigned programs
- Maintain a Lessons Learned log for all Project Teams
- Facilitate/Participate in the development and maintenance of Design Failure Mode and Effects Analysis (DFMEA) and serve as SME on criteria and methodology
- Ensure that customer requirements are incorporated into product functional specifications and lead risk and failure analysis (DFMEA/PFMEA) to ensure functional specification requirements and severity are fully met during design validation
- Facilitate/Participate in the development and maintenance of the new product Process Flows, PFMEA and Control Plans, including development of Special Characteristics (SCs) from the DFMEA
- Facilitate/Participate in the development of the SC Matrix (CC /SC)
- Work with ASQE to develop engineering drawings and material specifications, including designation of SCs from the DFMEA
- Attend DV/PV builds, Test Center reviews and verify compliance of product and process to the Control Plan
- Maintain communication with the selected manufacturing plant that will be running production and effectively handoff the Project Quality role to Plant Quality
- Lead problem-solving activities for internal and Customer concerns relating to assigned responsibilities and documenting all actions in the required format (eg. 8D)
- Initiate actions to prevent the occurrence of any nonconformance relating to product, process & systems
- Maintain communication with the ASQE group on project status and drive early involvement of suppliers
- To support selected new product launch, engineering changes and source / location change activities, offer technical assistance etc, working in conjunction with Dura’s Cross Functional Teams according to Dura’s Global APQP process
- Demonstrate through leadership, commitment to the principles of "Continuous Improvement" challenge suppliers on process/product technical solutions linked to the technology
- Within provided processes, ensure that statutory regulations specific to Health & Safety and Environment standards are adhered to and assessed for each assigned supplier
- To ensure the implementation and maintenance of all relevant operating procedures as defined in the Dura Integrated Management System and to introduce as necessary amendments, working in conjunction with the Corporate Purchasing and Quality Teams
- Completes and performs other duties/tasks as may be assigned
- Will be required to travel to various supplier locations and Dura plant sites globally
35
Advanced Quality Engineer Resume Examples & Samples
- Minimum of one (1) year combined quality engineering, product engineering and/or manufacturing environment experience
- Bachelor’s degree or higher in Engineering, Physics, Chemistry, Biology, Mathematics/Statistics, Science or related discipline from an accredited institution
- Minimum of three (3) years of quality engineering and/or product engineering experience
- Experience in manufacturing
- Lean Six Sigma training with proven ability to understand and apply Lean Six Sigma and other quality tools to product, systems and process problems
- Working knowledge of International Organization for Standardization (ISO) 9001 standards
- Test method development experience
- Excellent communication skills (oral, written and presentation)
- Self-motivated with proven ability to apply innovative solutions to problems
- Experience in the use of statistical tools
36
Advanced Quality Engineer Resume Examples & Samples
- Support and enhance product competitiveness by working closely with global quality team and regional Business leaders on quality data analysis and improvement, cost saving, etc
- Compile and analyze trending reports to identify opportunities to improve quality and decrease cost
- Ability to manipulate large data sets or other software tools
- Compile large presentations to be delivered to senior management team
- Demonstrate expertise in managing complex analysis and implementing improvement projects
- Review Quality Operations KPI’s for VSS (Value Segment Solutions) Business Unit
- Be able to manage multiple projects simultaneously while meeting active deadlines
- Support the compliance effort of the Quality team in BU VSS (Value Segment Solutions) and BG PCMS (Patient Care Monitor System)
- Manage the Document Control for VSS Shanghai site, working closely R&D project managers on documentation of Design History Files, etc. Review the document per the requirement in the document control
- Bachelor degree or above, engineering or statistics discipline is preferred
- At least 5 years experience in MEDICAL device industry is a Must, experience in Field Quality, statistic analysis related role is preferred
- Good command of English in reading, writing and speaking is a Must
- Strong understanding of Quality System regulations (i.e. ISO13485) is a MUST
- Good understanding of statistical methods, quality tools and methodologies
- Well-developed analytical skills
- Communicate globally across teams and programs
- Both detail oriented and able to see big picture
37
Advanced Quality Engineer Resume Examples & Samples
- Bachelor of Science required or an equivalent of minimum 4 years experience. Prefer a Bachelor of Science in Engineering or related field
- Minimum 4 years in quality development role or advanced quality experience in an active environment
- Proven track record of driving the development of successful project launches
- Experience in the creation / facilitation of Control Plans, FMEA’s, PPAP documentation
- Understanding of GD&T, special characteristics and MSA (Measuring System Analysis)
- Strong communication skills, verbal and written that span gap between development and manufacturing
- Excellent teamwork skills and a proven ability to influence others without formal authority
- Ability to travel globally up to 30%
- Experience in automotive electronics products
- Ability to demonstrate Project Management skills (timing and budget)
38
Advanced Quality Engineer Resume Examples & Samples
- Supports and coordinates activities related to maintenance of legacy products including
- Concept, development or updates of methods and processes
- Qualification of new internal manufacturing tooling and equipment
- Qualification and support of new vendor tooling
- Development, release or update of inspection and test documentation including control plans
- Support the plant with qualification and validation of new operations and processes including review of DOEs, validation protocols, data analysis and reports
- Evaluate and review recommendations from the plants for new materials and / or suppliers
- Works with project teams to determine proposed value of projects and associated risk
- Leads risk management and design verification activities related to sustaining engineering projects
- Leads testing of shelf life samples, and writes reports
- Determines need for biocompatibility testing, and leads the activity if required
- Conducts statistical analysis as needed in support of project teams
- Supports team to determine project objectives. Provides ongoing support to assure objectives are met
- Supports team in transfer activities from division to plant, or between plants
- Works directly with the plants and suppliers / labs to outsource testing when required
- Works on project teams in support of Post Market Surveillance activities for existing products
- Generates Risk Assessments for the impact of proposed changes on existing processes
- Works concurrently with Manufacturing Engineering, Quality Engineering and Regulatory Affairs groups in documenting product / process improvements or changes
- Supports / conducts Product and/or Process Design Review meetings
- Makes recommendations and/or assists Manufacturing Engineering in creating qualification strategies for upgrades to equipment and/or processes
- Supports the plants during analysis of complaint activities
- Supports Maintenance of Business activities as needed by the Davol Franchise teams
- May support New Product Development teams on an as needed basis
39
Advanced Quality Engineer Resume Examples & Samples
- Support product development by establishing product datum strategy and dimensional management plan during concept and design phases
- Co-ordinate dimensional analysis for parts, gauges, and fixtures produced by tooling/fixture design
- Validate initial product quality level in support of prototype and preproduction parts and tooling
- Establish priorities and direct activities of dimensional tech staff
- Conduct DFMEA / PFMEA activities with Design Leads, Validation Engineering Management, and Program Engineers. Follow up and track recommended actions to reduce potential design risk. Utilize warranty, corrective action, and similar part design information to develop potential failure modes
- Using this FMEA data and Customer/Design concerns, work with Design Leads and Manufacturing Engineers to build any check fixtures and/or assembly fixtures used to validate design
- Develop prelaunch control plans and support plant effort for initial production control plans
- Manage, justify and support quality equipment sourcing decisions in support of plant quality equipment, gauges and tooling
- Assist with PPAP completion and launch activities
- Provide Direction to Quality Lab or Plant personnel as required
- Work with Supplier and remote plant quality group to ensure design quality translates to Production quality
- Develop ongoing production dimensional data collection plan
- Attend warranty review meetings to assure failure modes are included in existing FMEAs
- Maintain customer required APQP documentation; speak as voice of ConMet quality
- Conduct QA/QC process on development pre-launch/prototype parts
- Work with customer and respond to corrective actions/8D items when requested
- Co-ordinate test requirements for development projects
- Lead standardization of FMEA process across company
- Assist on division wide quality initiatives
- Three or more years of related Quality Engineering experience required
- Plastic molding, assembly, and automotive experience a plus
- Must have experience in; Precision Metrology, MSA requirements, and Statistical Process Control, FMEA, GD&T and quality tools
- Working knowledge of dimensional management and design quality criteria. 3D tolerance stack analysis a plus
- Green Belt Required certification in Six Sigma required; Black Belt preferred
- CMQ/OE certification preferred
- Ability to work cross-functionally and manage various projects simultaneously (Required)
- Ability to effectively solve problems and lead problem-solving activities of a team (Required)
- Ability to interpret GD&T (Required)
- Knowledge of current AIAG PPAP requirements (Required)
- Knowledge of AIAG FMEA methods (Required)
- Knowledge of AIAG MSA standards (Required)
- Skilled in PowerPoint, Excel, Word (Required)
- Technical Procedure writing experience (Preferred)
- Knowledge of Polyworks and/or PC-DMIS Dimensional inspection software (Preferred)
- Knowledge of casting and injection molding visual defects and causes (Preferred)
- Advanced ability to apply statistical techniques in practical solutions
- Self-directed, with strong communication and interpersonal skills
- Effective communication skills with all team members and customer representatives
- Strong Metrology capabilities
- Technical Skills: Possesses, acquires, and maintains the technical/professional expertise required to do the job effectively and to create client/customer solutions
- Distinctive problem solving and analysis skills, combined with impeccable business judgment
- Candidate must be willing to, and have the flexibility to provide support for a continuous operations production environment
- Ability and willingness to travel up to 30% of the time and work extended hours based on customer demand and production schedule
- Working knowledge of AutoCAD/and other cad viewers
- Time Management: Organizes work, sets priorities, and determines resources requirements; determines necessary sequence of activities needed to achieve goals while effectively managing time with limited supervision. Ability to manage multiple high priority projects simultaneously
- Adaptability: Adapts well to changes in assignments and priorities; adapts behavior or work methods in response to new information, changing conditions, or unexpected obstacles; approaches change positively and adjusts behaviors accordingly
- Collaboration: Builds constructive working relationships with clients/customers, suppliers, other departments, organizations to meet mutual goals and objectives. Behaves professionally and supportively when working with individuals from a variety of ethnic, social and educational backgrounds
- Ability to speak Spanish is a plus, but not required
40
Advanced Quality Engineer Resume Examples & Samples
- Responsible for achieving our customer’s quality requirements
- Responsible for defining a safe launch plan including exit criteria
- Responsible for MSA, PFMEA and control plan development
- Work closely and build relationships with our customers
- Participate in validation of new manufacturing processes
- Lead cross functional meetings to review all quality documents and status updates. Report items with highest risk to management, develop plan to reduce/eliminate risks whenever possible
- Lead problem solving activities
- Support Product Development with GD&T analysis
- Support Product Development with prototype build validation
- Support the plants with PPAP activities
- Support the successful resolution of quality issues on current product
- Drive the standardization of quality documentation and systems across multiple manufacturing facilities
- Bachelor’s Degree in Engineering or equivalent technical Bachelor's or Master's degree required
- Two or more years of related experience in Advanced Quality Engineering required
- Foundry, CNC machining, plastic molding, assembly, and/or automotive experience preferred
- Six Sigma Green Belt or Black Belt training preferred
- Experience working hands on in a manufacturing environment
- Excellent organizational, and analytical skills
- Strong computer skills in MS Office, Mini Tab (other statistics software)
- Strong attention to detail, decision making, and work ethic
- Able to adapt to change and cope with complexity in a fast paced environment
- Able and willing to travel up to 30% of the time and work extended hours based on customer demand
41
Senior Advanced Quality Engineer Resume Examples & Samples
- With B.S., minimum of 5 years experience / with M.S., minimum 4 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
- Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 9001
- Ability to travel up to 20%
- Strong Design Control understanding from concept to launch; including post-market activities, complaints analysis, failure investigations, and CAPAs
- Prior experience interacting with Surgeons a plus
42
Advanced Quality Engineer Resume Examples & Samples
- Core project team member, representing quality and assuring quality on product
- Responsible for achieving quality objectives in the project in the design and development phase
- Develop Product Quality Plan, considering customer, durability and reliability requirements
- Implement and lead design robustness activities in project or program
- Supports benchmarking and competitive analysis activities
- Drive Design for Value (DfV) activities related to quality (or DFSS – Design for Six Sigma)
- Assessing and evaluating test methods in verification and validation phase
- Evaluates design concept and participate in design review to meet quality objectives
- Co-sign design review document
- Using statistical techniques to create sampling plans and execute data analysis
- Supports Design Failure Mode and Effect Analysis (DFMEA), assures that associated risks are monitored and actions are defined to mitigate risk
- Creates Prototype Control Plans
- Conduct lessons learned, read-across workshops and verifies that Design Guidelines are updated
- Supports project team to identify relevant field use cases
- Conduct Critical to Quality Validation (CQT-Validation) prior to design release
- 5 years of experience in Engineering required
- 3 years of experience in automotive industry preferred
- Lean Six Sigma experience, specifically leading Green Belt or Black Belt projects required
- Broad understanding and application of statistics and risk assessment tools preferred
- Test method development and Validation experience preferred
- New product development and introduction experience required
- Excellent attention to detail and process/system orientation required
43
Advanced Quality Engineer Resume Examples & Samples
- 1) Be responsible for Production Quality Assurance Planning for new projects, products
- 2) Be responsible for submit OTS & PPAP documents to customer
- 3) Develop application of quality specifications in both the customer requirements and product specifications
- 4) Confirm with customer about any change in the new program , follow& transfer the customer change requirements
- 5) Collaborate closely with function team and keep making continuous improvement on new program development
- 6) Conduct the management of the Inspection Characteristics and product Inspection plans
- 7) Full responsible for the audit in new program and conduct handling the quality complains by customers
- 8) Coordinate internal quality issue solve
- 1) More than 3 years of prior experience in quality engineering
- 2) Be familiar with TS16949
- 3) Proficient knowledge of APQP & PFMEA& Control Planning& SPC& MSA
- 4) Skilled in reading drawing, GD&T. Be master of mechanical and gauge development,
- 5) Learn plastic and metal parts technology
- 6) Understanding and experience about manufacturing processes is perfect
- 7) Risk analysis in new program & Quality issues solve
- 8) Knowledgeable in the application of Product/Process standards of Customer Quality Requirements
- 9) Negotiation and conflict resolution skills
- 10) Demonstrated good written and verbal communication skills with ability to communicate effectively in Mandarin and English
- 11) Could travel irregular
- 12) Any other tasks assigned by supervisor
44
Advanced Quality Engineer Resume Examples & Samples
- Responsible for the application of customer quality requirements, including special characteristics and traceability within the CAPM/APQP framework
- Support design and manufacturing functions during all stages of the CAPM process. Participate in stage gate and programme reviews
- Support the identification of Programme Risks through the application of PFMEA, past concerns, and lessons learned
- Participate in the development of the Process Flow/PFMEA/Control Plan. Review special characteristics in deployment
- Verify that engineering, process intent, and production samples are manufactured and inspected according to SAFE Sample and customer specific requirements
- Develop strong working relationships with customers and support on-site visits
- Responsible for preparing and leading the Product Launch Quality Reviews (PLQR) and coordination of related Product Launch Quality Improvement Plan (PLQIP)
- Complete and submit PPAP documentation for approval and ensure it includes approved changes
- Ensure PSW (Parts Submission Warrant) is signed off prior to the start of production
- Responsible for training, implementation, follow-up, and closure of Initial Mass Production Quality plan (SAFE LAUNCH)
- Support problem solving activities and ensure timely feedback to the customer on product launch concerns
- Undertake training when identified to improve business capability and allow for changes in technology and quality requirements. Continuously improve Advanced Quality processes
- Adhere to the GKN Product Safety Policy and Product Safety Procedure
- Immediately report PPSI (Potential Product Safety and Integrity) concerns to the Quality Manager in production or the Chief Engineer in development
- Confirm all deliverables in the GKN Product Safety Sign-off (PSSO) checklist are complete as defined in Stage C – Customer Application Programme Management (CAPM)
- Specific Functional Capabilities, Knowledge and Skills Required
45
Advanced Quality Engineer Resume Examples & Samples
- Define the Past Problem History Roadmap and lead a cross-functional team within SDT ensuring applicable issues are closed before first customer part requirement
- Develop the Prototype, Pre Production and Production Control Plans for the program
- Develop the Measurement System Analysis Plan for the program. Responsible to ensure variable and attribute Gage studies are conducted on all gauging and improve Gage R&R where data indicates need
- Responsible for implementation of the Manufacturing Quality Systems for the prototype, pre-production, and production builds as defined in BOS and/or specified on the Production Control Plan. 5. Responsible for completion of inspection reports for components that are used for pre-production product builds
- Perform capability studies and document the results for all program special characteristics ensuring that Customer and internal requirements are met
- Responsible for color/appearance approval from pre-grain to PPAP, including proper Customer submission paperwork
- Responsible to coordinate the preparation and on-time delivery of PPAP packages for submission and approval by the Customer
- Responsible to coordinate with the SAQE the preparation and on time delivery of supplier quality deliverables including: Control Plans, Capability Plans, Capability Studies, Part layouts, Gage design, Gage R&R, PFMEA, and DFMEA
- Utilize all applicable Customer-specific systems
- Ensure appropriate statistical methods are utilized throughout the Product and Process Development process and deployed into the Control Plan
- Responsible for completion of all other Customer-specific Advance Quality requirements
- Ensure Customer, internal, and supplier quality issues are resolved using problem solving methods
- Develop appropriate inspection and containment plans for pre-launch builds. Perform job functions in accordance with set policies and procedures to ensure preservation of the Company Ethics and Quality Policy
- 5+ years of technical experience in specific education and training in Quality disciplines is required, including (minimum): ISO/TS16949, Continuous Improvement, Total Quality Management, PPAP, FMEA, Control Plans, DOE, and SPC
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Advanced Quality Engineer Resume Examples & Samples
- Statistics and Risk Management tools
- Testing and validation tools
- Product development
- Six Sigma (preferably Green Belt or Black Belt)
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Advanced Quality Engineer Resume Examples & Samples
- With B.S., minimum of 3 years experience / with M.S., minimum 2 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving
- A high level of competence in all qualifications of the AQE
- Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs)
- Experience with BioSurgery applications including sealants and hemostat products preferred
- Knowledge of active pharmaceutical ingredients, excipients, and chemical applications a plus
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Advanced Quality Engineer Resume Examples & Samples
- Point of contact for Uconnect Product Development Quality Organization
- Point of contact for all product strategic improvement plan
- Implementing lessons learned in new Uconnect platforms using CQI and 3rd party metrics
- Negotiate new and improve features with Planning organizations and stake holders
- Develop and Support business cases with partners
- Creative solutions for Voice Recognition and Device Connections
- Collaborate with HMI and PDO on the definition of new features
- Monitor requirement definition and supplier Q&A activities
- Improve software delivery state for Plywood buck. I.e. greater feature completion, stable software
- Define metrics to monitor and track progression
- Bachelors of Science in Engineering discipline (Electrical, Computer Science, Mechanical)
- Valid Driver's License
- Experience in Automotive, Computer, or Cellular industries
- Computer literate required (i.e. Outlook Mail, Excel, Word)
- Excellent data analytical skills
- Excellent communication skills; both verbal and written
- Quality and or Infotainment experience is preferred
- Previous leadership experience is a plus
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Advanced Quality Engineer Resume Examples & Samples
- Co-ordinate and lead the relevant quality and problem prevention activities
- Ensure completion and verification of all mitigation actions for past concerns
- Verify that the product launch quality deliverables specified in the management system are completed to a high standard of execution and meet customer requirements
- Develop strong working relationships with customers and support contract review to ensure customer specific requirements are transferred to program team members for integration into the project plan
- Prepare, update, and maintain the quality relevant documents for the program
- Complete a control plan audit of run at rate build
- Produce regular reports on the APQP status, including customer specific reports
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Regional Advanced Quality Engineer Resume Examples & Samples
- Lead Advance Product Quality Planning for New Product Development (NPD) programs as assigned. Involves coaching and mentoring team members as well as the development and use of process documents/tools such as DVP&R, FMEA, control plans, PPAP, Early Launch Containment, etc. to ensure quality deliverables are met throughout each phase of the new product launch process. Includes management of the Production Part Approval Process for both internal and external suppliers
- Track and communicate project status of quality deliverables as they relate to Design Readiness, Part Readiness and Manufacturing Readiness
- In addition to ensuring that Advanced Quality Planning (AQP) is adequately resourced, the AQE will be responsible for some of the hands-on new product launch activities within Commercial HVAC manufacturing locations and manufacturers of Trane branded products
- Serve as core team member of New Product Development team and ensure that program goals, including quality and reliability, are met
- Develop AQP plans for NPD programs; ensure that resources are obtained as required from Operations, Engineering, Supply Chain, Suppliers and other required functions
- Lead AQP and PPAP activities for both internal and external suppliers including DFMEA, PFMEA, and Control Plans
- Leverage outside resources, best practices, internal consulting and past experience to ensure that Commercial HVAC SBU business objectives in new product development are met
- Travel to supplier and Commercial HVAC facilities will average 25%. Must have the ability to be self-managed when working in a virtual/remote team