Senior Quality Manager Resume Samples

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M Rodriguez

Mercedes

Rodriguez

96061 Howe Fields

Houston

+1 (555) 652 3234

96061 Howe Fields

Houston

Phone

p +1 (555) 652 3234

Experience Experience

Houston, TX

Senior Quality Manager

Houston, TX

Gusikowski, Wisoky and Keeling

Houston, TX

Senior Quality Manager

Provide leadership and develop and implement methods to improve teams’ effectiveness and performance versus established quantitative measures
Train and develop QC managers and SQE; make department training plan
Establish and manage departments performance metrics and goals
Facilitate resolution of issues by working with Project Quality Managers and Project Managers
Develop and improve relationships with key Suppliers through projects and improvement strategies
Manage a team of quality program managers building and improvement the data transformation quality processes
Utilize quality system performance KPI to drive performance improvement

New York, NY

Senior Quality Manager / Engineering

New York, NY

Gottlieb, Hermiston and Funk

New York, NY

Senior Quality Manager / Engineering

Provide Quality Systems leadership using recognized standards as the basis for process development and optimization, procedure development, data collection, and Quality Systems training
Develops and maintains the Program Quality policy, processes, procedures, and related documents. Reviews Quality Manuals, documents and implementation procedures to verify compliance with industry codes and standards, and regulations
Participates in Client Quality planning and preparation meetings
Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including design and construction phases of each element, as well as program-wide activities
Manage the Program Quality Management team for each element during mobilization, implementation, and closeout phases
Develop and manage quality training program
Manage the Quality team in the oversight of developers/contractors' quality programs for each element via the following

present

New York, NY

Senior Quality Manager / Quality Manager

New York, NY

Olson-Goyette

present

New York, NY

Senior Quality Manager / Quality Manager

present

Assist in establishing robust and consistent evaluation methodology ensuring reporting of adverse events are consistenly applied across all Dx sites
Provide quality support for the Dx service organization and partner with local sites for improvement activities
Drive continuous improvement and LEAN activities with the sites to improve efficiencies in post market activities
Manage regional quality managers in Mexico and APAC to suppor the Dx business
Ownership responsibility for the Dx business level QMR, establishing and disseminating metrics applied across all sites
Function as the Subject Matter Expert on post market surveillance matters
Function as the Dx champion for IT projects impacting the Quality function and/or systems

Education Education

Bachelor’s Degree in Scientific

Harvard University

Bachelor’s Degree in Scientific

Skills Skills

You will have a strong solutions focus and be comfortable working in an environment which demands strong deliverables
Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
Strong experience in using HP Quality Center tool. Quality Center Admin activity as an added advantage
Strong working knowledge of ISO Quality Management Systems Standards
Strong quality management credentials, with at least 5 years of experience managing teams, ideally with hands-on quality improvement experience
Good knowledge of audit methods and quality improvement tools (Statistics)
Strong technical skills in the manufacturing of solid oral dose, semi-solids, devices, and biologics
Good and proven ability to analyze and evaluate Good Manufacturing Practice compliance
Ability to attend to detail and work in a time-conscious and time-effective manner

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Senior Quality Manager Resume Examples & Samples

Manager China QA/QC team;organize effective working process in SE departments among offices in different places
ITS setting up for the audit and inspections in Vietnam and Taiwan
Weekly / Monthly report to HQ management team
Build up strong SE department team; team manpower and schedule monitor, coordination and application
Business travel within China, VC meeting with HQ PM periodically for working communication and solving quality problems
QC manual building up, translation, compile working and monitoring
Train and develop QC managers and SQE; make department training plan
Make team KPI and appraisal review; set up QC working policy, monitor and evaluate achievements
Factory audit conduct before SQE team setting up
PPS control before the production season

Senior Quality Manager Resume Examples & Samples

Establish Quality Operating Systems with adherence to all the global standards as required in marketplace
Ensure compliance to certification agencies
Conduct internal audits and ensure corrective actions
Provide reports and documentation of key measurables as required, and maintain a system for communicating ongoing performance
Report on the performance of the quality system to the management team
Represent the needs of the customer in internal functions in addressing quality requirements
Represent Quality function in dealings with external parties like customers or suppliers
Provide conduit to Magna International Corporate Quality initiatives for continuous improvements
Manage departmental and program budgets for Quality Activities
Report on Cost of Quality metrics
Support standardization of processes and systems between corporate and manufacturing plants
Support Failure mode and effects management in design and manufacturing phases (DFMEA and PFMEA)
Provide sign-off on design, drawings, validations to seek sign-off from customer
Ensure effective change management process and tools for internal and external changes
Manage direct reports, dotted line personnel, and other employees to accomplish company / program goals
Motivate all company personnel to focus on Total Quality
B.S. in Science or Engineering or related technical field
Minimum 5 years in leadership roles in manufacturing organizations
Hands on knowledge of automotive business, manufacturing processes
Excellent interpersonal and communication skills both written and verbal
Experience in training, coaching and moderating meetings
Strong PC skills in excel, visio, powerpoint and internet applications
Superior organization, multi-tasking skills
Although this position is based in a corporate office environment, frequent visits and stays at manufacturing plants environments may be required
Although travel is not an inherent part of this position, it may be frequently required as needed between corporate office, manufacturing plants, suppliers etc. with little or no notice
International travel may be required. Valid passport and entry document for US are required

Senior Quality Manager Resume Examples & Samples

As a management representative of TS16949/ISO14000, and ensuring establish, implement and continuously improve the quality system and policy required by the development of plant and customer
To ensure that the company's products and service to meet the quality requirements of the customers, including the establishment and reach of quality objectives of the organization, the formulation and implementation of corrective and preventive measures and the continuous improvement of quality
Be responsible for establishing new method and balancing standard of quality management; organizing a variety of continuous improvement activities within the plant
Be responsible for operation supervising and internal audit activity of management system, and examining and put forward disposals of the implementation of management system in all department
Implement product quality management process and guarantee the product quality
Be responsible for solving problems of quality
Leading the quality management of suppliers
Leading the cost management of quality
The quality department; finishing operating and financial budget
Minimum 5 years quality control experience in manufacturing industry, auto parts industry is preferred
Be familiar with 5 tools(APQP, MAS,FMEA,QFD and 6 sigma)
Be familiar with quality management system(i.e. VDA6.1, TS16949, ISO14000)
Be familiar with quality management skill and have experience in compiling QSD
Bachelor degree in automotive manufacturing, technician or related subject or above
Be skilled in using office software
CET4, be fluent in oral and written English
Work diligently, think clearly
Good communication skill and team work spirit, good sense of coordination, good project management skill and problem solving

Senior Quality Manager Resume Examples & Samples

Define quality measures for onsite product listing to influence conversion rate
Gain a deep understanding of all processes used by cross functional teams to add and update products onsite
Define quality metrics for all processes at various stages and work with each team to measure, monitor and tracks these results
Identify core issues via root cause analysis, do not settle for mediocrity
Propose improvements to current workflows to increase product quality metrics. The improvements will cover optimizations needed across many different processes, tools, vendor communication and more
Drive the implementation of the proposed improvements across teams and monitor progress
Gain alignment across teams and with senior leadership using data driven approach and a customer centric view
You have solid knowledge of all areas of quality and/or compliance based upon practical experience, including root cause problem solving (e.g., 8D, CAPA), quality gates, Six Sigma, cGMP regulation, and/or remediation
You have professional experience in introducing and implementing quality and compliance concepts
You have an excellent university degree, with a technical or business specialization
You have outstanding analytical and conceptual skills
You show great initiative and creativity, working well both on your own and in a team
You are able to convince others through your written and spoken communication
Experience in Consulting or Service industry or e-commerce with quality and process improvement a plus

Senior Quality Manager Resume Examples & Samples

Implement and drive a process of continuous improvement and cost reduction at the site by embracing ACE/Lean principles and tools including Kaizen, Value Stream Mapping & other related methodologies to achieve highest quality, lowest cost & customer focused standards
Lead and develop talent within the quality organization
Lead the site in complying with the Quality Management System (QMS)
Responsible for the preparation and maintenance of the plant Quality Assurance Program, FAA Repair Station Manual, and the North Carolina State Radiation Safety Manual
Responsible for the preparation and maintenance of Quality Procedures to support the Quality Assurance Program
Lead and delegate third party inspection services and direct the activities thereof to support plant quality and manufacturing objectives
Responsible for the preparation and maintenance of the nonconforming materials program
Responsible for external and internal quality audits, source inspection, including the reporting of findings, recommendations, nonconformance and suitable corrective actions
Responsible for the review of customer proposals prior to contract resulting in exception, clarification and/or comment
Provide first point contact with customers, vendors, and regulatory representatives on all communications regarding Quality Assurance
Responsible for the monitoring and analysis of scrap and rework costs; serve as a primary member of the Material Review Board
Actively support the Company policies, procedures, and workplace rules including environmental, health, and safety objectives to ensure compliance, keep our people safe and minimize risk
Responsible for compliance to all UTC, UTAS and outside regulatory policies and procedures

Senior Quality Manager Resume Examples & Samples

Quality culture program: as role model to promote TQM culture in whole business unit
Quality system/ legal compliance: ensure Mars Quality Management System fully implement, maintain and continuously improve in end to end process. Ensure full legal compliance
Continuous improvement: leading TPM QM pillar to drive quality continuous improvement
Quality capability building: talent expert in quality team, quality ownership with capable quality knowledge in operation team
Quality Team building: high engaged team with strong quality capability
Education & Professional Qualification

Senior Quality Manager Resume Examples & Samples

Develops and manages the implementation of the strategic quality plan and ensures alignment / priority setting with strategic business plan and the alignment of appropriate resources. Guides business in making appropriate risk / reward decisions associated with product and service quality
Oversees the development, implementation, and maintenance of effective, fact-based processes for establishing final product specifications and manufacturing specifications, and maintaining consistency between them
Oversees implementation of global Quality initiatives. Develops project plans, allocates resources and manages project team members across locations in achieving project goals. Determines priorities and manages budgets and other resources
Ensures ongoing compliance with ISO and Quality systems requirements and ensure total quality excellence in all activities. Ensures that manuals are updated and lab procedures are standardized at all plants in the region. Follows up on regional and other audits and oversees corrections and improvements
Coordinates business complaints database, providing customer complaint resolution both at the plant and business levels. Works with cross-functional groups as needed to ensure solutions are found that meet both the customer and Cabot’s standards
Ensures that the business or region has appropriate technical strengths in the areas of analytical chemistry, statistical methods and laboratory management

Senior Quality Manager Resume Examples & Samples

The Senior Quality Manager will coordinate with the Director of Quality Operations and Facility General Manager and assure that PharMEDium’s core values are continually emphasized and kept in the forefront of facility operations
Will be responsible for all daily quality operations within the facility. Ensures compliance to procedures, governing regulations and addresses non-compliance issues
As the leader of Quality in the Center the Senior Quality Manager will set the tone for quality processes and services to deliver safe compounded preparations to hospital customers
Working with Facility General Manger will assure timely closure of audit items
Will initiate SOP revisions as needed to assure compliance, continuous improvement of overall operation
Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the Center processes
Coordinate and schedule testing of all compounded services for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner)
Perform review of quality related documents generated at the Sugar Land facility
Coordinate efforts with the Director of Quality Operations in the management of the Facility Testing Laboratory. Will ensure the day to day operation of the lab is meeting its testing goals in a precise, accurate and efficient manner
Bachelor’s Degree in Science or related field
Aseptic processing experience desired
Minimum of 10-15 years’ experience in Quality, or related field in the healthcare or pharmaceutical industry
5-7 years Management experience
Demonstrated understanding of quality assurance in a regulated (FDA, DEA, ISO) environment
Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills

Senior Quality Manager Resume Examples & Samples

Develops and maintains a quality plan for one or more service center operations and programs, including service quality standards, quality scorecards, monitoring, coaching, performance metric assessment, and improvement actions
Manages a team of Quality Supervisors, Monitors and/or Specialists, establishing roles, work standards, performance objectives, and enforcement through regular oversight
Monitors and reports program performance against service level agreements and performance standards, initiating improvement actions when opportunities are identified
Represents the quality function to clients, serving as a point of contact for quality inquiries
Conducts process and product audits to confirm compliance with company policies
Effective supervisory skills
Proficiency with MS Office Products: Word, Excel, PowerPoint, Project

Senior Quality Manager Training & Compliance Resume Examples & Samples

Collaborate closely with NBS training functions, NBS QA functions and Group Quality Training to create alignment across the business, optimize cross-functional GxP training strategies, cross-organizational synergies, and improve transparency of cross-functional GxP training standards and requirements. Provide periodic scheduled reports on progress against process improvement objectives
Drive the design and implementation of robust quality-related training programs (e.g. Novartis quality requirements, GxP, SOPs, etc.) to facilitate continued growth and development of NBS personnel
Define and implement the strategy for new quality processes, systems, and standards related to QMS training activities
Drive structure, tools and processes to ensure highest quality standards for both internally and externally developed learning solutions and operational technologies, while maximizing the effectiveness of learning and training com-pliance
Act as SPOC for audit and inspection queries from a NBS training and compli-ance perspective, as required. Oversee the implementation of corrective and preventive action plans resulting from Health Authority inspections or internal Novartis quality audits related to NBS training processes

Senior Quality Manager Resume Examples & Samples

Ensure timely resolution of Customer quality issues through leadership within the ADD Quality Management system
Responsibility for GSCQA Operations at ADD Manufacturing sites; TPMs and approved Supplier base worldwide
Develop and improve relationships with key Suppliers through projects and improvement strategies
Position requires domestic and international travel as well as outstanding relationship and interpersonal skills
Support the continuous improvement of the GSCQA Organization
Go / No-Go decisions related to Supplier selection
Lead efforts to harmonize and simplify GSCQA processes
Monitor quality performance (Supplier / Customer Complaints) and elevate through the appropriate channels

Senior Quality Manager Resume Examples & Samples

Performs Drug Product batch disposition activities upon review of executed batch records, analytical data, and certificate of analysis for commercial drug products (oral dose)
Provides quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
Develops relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and manages ongoing relationships
Represents Vertex Commercial Quality Assurance on cross functional working teams and is recognized for strong communication and influencing skills
Models Vertex Core Values and leadership behaviors and fosters their demonstration in others
Experience with drug product (oral solid dosage forms) development with proficient knowledge of the following in a pharmaceutical setting

Senior Quality Manager Resume Examples & Samples

Serves as a CQA Compound Lead for assigned clinical programs providing GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects’ safety, rights, and well-being as well as the integrity and credibility of data generated
Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP)
Fosters Vertex Core Values when collaborating with cross functional teams to advance quality activities while remaining independent and autonomous
Responsible for developing strategic audit plans assigned programs, ensures audits are conducted in accordance with the plan, evaluates CAPA plans and drives CAPAs to closure in accordance with company standards and policies
Manages and/or leads domestic and international audits for Clinical Investigators, Trial Master Files (TMF) and/or GCP document audits to ensure compliance to ICH GCP, applicable regulations, and company standards
Assures reporting of potential or confirmed violations, as appropriate, in accordance with company standards
As assigned, reviews and approves audit reports for content, format, regulatory risks, and compliance with applicable standards
Identifies and escalates critical quality issues appropriately to CQA Associate Director for Quality Oversight of Clinical Programs
Contributes to the development and implementation of continuous quality improvement initiatives
Provides inspection support as necessary for Regulatory Agency inspections held at Vertex facilities or Clinical Investigator sites
Nine years of relevant GCP QA work experience, or relevant comparable background and 5 years of relevant GCP QA experience
In depth knowledge of FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments and ICH GCP guidelines
Experience with clinical trials involving drugs, biologics, devices and drug/ device combinations
Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers
Possess the necessary scientific education and knowledge to manage quality oversight for clinical trials, understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects
Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines
Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint)
This position may require up to 30% travel

Senior Quality Manager Resume Examples & Samples

Bachelors or Master’s Degree in Engineering, Business or College Diploma
5 years Aerospace Quality experience
5 years Management/Supervisory experience
10+ years of experience dealing with quality management systems, regulations, guidelines and associated standards preferably in an aerospace manufacturing environment and experience with Canadian Aviation Regulations related to Manufacturing and Maintenance of aeronautical products
Leading Lean and/or Six Sigma initiatives
Broad knowledge of safety in aviation operations and the aviation regulatory framework (TCCA, FAA, EASA or other NAA’s); ability to provide guidance to Contract Manufacturer to ensure compliance in the Honeywell Manufacturing Policy Manual and Maintenance Policy Manual
AS9100 and/or ISO 9001 knowledge and experience on regulations, guidelines and associated standards
Experience in successfully taking companies through required quality management certification processes and audits (AS9100, Regulatory, Customer etc...)
Experience in Management (training and development) of staff in various disciplines of quality (Customer Quality Engineers, Quality Engineers, Auditors, Inspectors)
Proficient with Microsoft Office tools such as MS Word, Excel, and PowerPoint
Practices and maintains integrity while following company requirements
Creates a positive work environment by demonstrating and sharing functional/technical knowledge
Ability to interface easily with customers and suppliers as the quality leader in the Integrated Supply Chain. Proven track record in building and maintain lasting relationships with other departments, key business partners, and government agencies
Excellent communication skills for liaising and communicating with Contract Manufacturers, external suppliers, customers, and internal departments
A well-defined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills. Must maintain a sense of urgency to resolve quality issues

Senior Quality Manager for SAP Custom Development Resume Examples & Samples

Managing the quality assurance activities for the full lifecycle of the development projects Supporting different project methodologies like waterfall and scrum
Being a decisive member of large project teams advocating the quality of the solution
Ensuring together with the project team that the project meets customer expectations
Alignment with other departments like Solution Validation department or production unit concerning quality activities
Coaching and consulting of development projects regarding Custom Development methodology and processes
Project assessments and audits
Improvement of QM processes and tools within SAP Custom Development methodology
Advising customers regarding quality related topics throughout the whole project lifecycle
SAP Custom Development takes care for its new team members. Therefore we will provide different kind of support to get you started for instance trainings and mentoring
Test execution in the assigned projects
Strong quality and customer focus
Flexible and quickly adopting to new tasks
Good project management skills is a plus
Knowledge of I2M tools and I2M processes for Standard Development is a plus
Knowledge of agile development processes
At least 3 years of experience in Quality Management or Project Management
Experience in working with cross location and multi-cultural teams
Experience with new technologies like UI5 or hybris is a plus

Senior Quality Manager Resume Examples & Samples

Drive a Zero Defect culture by managing controllable root-cause defects and ensure implementation of controls and minimize losses
Own the development of robust quality feedback loops into training, analytics, and process to drive continuous improvement
Interact with stakeholders at multiple levels and dynamically lead business and product teams to define and deliver solutions to establish quality standards and processes
Identify and analyze data to isolate issues, identify trends, develop solutions and prioritize opportunities for overall process improvements
Create, maintain and disseminate project information to stakeholders and senior management
5+ Years project/program/operations management within a quality environment
Experience with Six Sigma tools and Lean techniques
Maintain a positive and professional demeanor always portraying the company in a positive light and effectively managing sensitive issues
For us, the culture fit is non-negotiable – you will have high energy, fantastic communication skills and huge amounts of drive
Quality management in a contact center environment
Advanced analytics background
Additional European languages
Experience with Lean and/or 6 sigma methodologies

Senior Quality Manager Resume Examples & Samples

Leads and manages customer audits and regulatory/compliance agency audits
Reviews weekly quality performance with CFT/BU management team and customer to drive for problem resolution and continuous improvement
Works as a partner with suppliers to ensure that the material spec. is followed, the process is under control to ensure the material quality and on time delivery
Identifies the potential risk to product long term reliability in the end to end manufacturing process and drive for proactive solution
Typically requires 8 years’ experience in PCBA manufacturing, assembly and integration process, and at least 4 years works as Quality Manager
Demonstrates maturity of people/process management and communication skills
Good command of English and Chinese
Lean Green Belt and Six Sigma Black Belt certification are preferred
Characters of Intense Collaboration, Passionate Customer Focus, Thoughtful Fast Discipline Execution and Tenacious Commitment to Continuous Improvement

Senior Quality Manager Apparel Resume Examples & Samples

You lead a team of 4 and you play a central role in the strategic quality management
You are the lead for quality management projects and you follow them through until the end
You set new strategies for the quality management in collaboration with other quality control@source pillars and the quality control inbound
Your set KPIs for the evaluation of your team members, 3rd party providers and the quality control abroad
You manage data analysis in order to identify weaknesses and strengths in structures
You develop SOPs, guidelines, manuals and requirements for 3rd party provider and quality control abroad
You support the team lead in budget planning and hiring process management
Your take care of efficient utilization of resources as well as train and develop team members
Your steer all activities in the quality control@source team; enhance, standardize, monitor and develop quality management processes internally
You provide support in the existing product lifecycle management systems
You are the interface for our Stakeholders
You report autonomous to the team lead quality management
You drive seasonal reviews for our supplier performances
Boredom doesn't get a look in here! Zalando is a working environment where something new happens every day A corporate culture where your skills are judged only by your results - our motto: Every Day is a Casual Friday
A dynamic and highly motivated international team of experts to inspire and support you
Also a feel-good team: We don't just work well together, we also like to get together after work
Training and further development opportunities to expand your skills and help you on your way
The security of an expanding company with more than 10,000 employees and a company pension scheme
Everything your retail-loving heart could desire thanks to our attractive employee discounts in our online shop

Senior Quality Manager Resume Examples & Samples

Global Test Machine Product Line Quality Leadership for Ultrasound testing machines (UTTM)
Site Quality Leader and responsible for sites in Huerth (Germany), Nove Mesto (SK) and product quality produced by other IT manufacturing sites
Drive continuous cross functional efforts to improve key site metrics: Productivity, Manufacturing Defects, Rework, Cost and Customer Satisfaction
As Site Quality Leader responsibility to manage (ensure, maintain and improve) site Quality Management System (QMS)
Establish, monitor, and drive improvements for Site and product line quality goals including: audit program, corrective action (CA) system, customer issue resolution (CIR) cases, Net Promoter Score (NPS), Cost of Quality (CoQ), on-time delivery (OTD), continuous improvement (CI), Technical Regulations and Standards (TRS) compliance, and other relevant metrics for the location
Work closely with the site leadership to drive quality and LEAN programs and raise quality culture and awareness at site and other related functions like Services etc
Be voice and advocate of our customers
Lead Quality team
Relevant professional experience in Quality
Experience implementing and influencing quality metrics
Strong personality and Change management process
Fluent German/English speaking skills
Lean Six Sigma GB/BB
Ability to document, plan, market, and execute programs

Senior Quality Manager Resume Examples & Samples

Bachelors or Master’s Degree in Engineering, Business or equivalent related education
10 years Quality Management experience
Broad knowledge of safety in aviation operations and the aviation regulatory framework (TCCA, FAA, EASA or other NAA’s)
AS9100 and/or ISO 9001 knowledge and experience on regulations , guidelines and associated standards
Sound knowledge to be able to provide expertise in the airworthiness standards and processes described in the Honeywell Manufacturing Policy Manual and Maintenance Policy Manual in compliance with TCCA requirements
Experience in training and developing personnel at all levels in quality management
Experience in Management of staff in various disciplines of quality (Customer Quality Engineers, Quality Engineers, Auditors, Inspectors)
Experience with Microsoft Office tools such as MS Word, Excel, and PowerPoint
Displays leadership qualities and practices
Strong work ethic and positive team attitude
Able to interface directly with cross-functional teams
Able to build and maintain lasting relationships with other departments, key business partners, and government agencies
Promotes and seeks excellence in all aspects of quality and compliance
Good presentation skills including presentation to Senior Management

Senior Quality Manager Resume Examples & Samples

4-year degree in Electrical Engineering, Quality discipline or related field experience as an inspector (or equivalent work experience)
A minimum of 15 years of related work experience in the field of Quality, including 7 years experience in a management capacity
Lead Auditor certification (ISO 9001 or equal) or ASQ certification (CMQ/CQE.)
Active membership in a nationally recognized Quality organization
Materials, methods, regulations and requirements relative to the construction of electrical and related facilities associated with building, radio antenna structures and related projects
Defects and faults in electrical construction installations
Tools, surveying instruments and equipment used in construction projects
Basic mathematics including algebra, geometry and trigonometry
Working knowledge of "Codes and Standards" listed below
Electrical installation best practices
National Fire Protection Association (NFPA)
Ability to communicate clearly and concisely, orally and in writing with a diverse group of professionals
Requires management ability and extensive knowledge of Quality Management practices, processes and current technology
Requires thorough experience in directing and implementing quality management systems and standards specified by ISO 9000, ASME, ANSI, ASTM and similar organizations
Requires the ability to communicate clearly, conduct presentations to management and interface effectively with a diverse group of professionals
Proficiency in analyzing situations in business terms, i.e. ROI, cost per unit, etc
Strong interpersonal skills to work with other departments in a tactful and effective manner
Strong leadership and management skills, excellent written and verbal communication, strong analytical, problem solving, and risk assessment skills. Ability to make public presentations
Computer proficiency with advanced knowledge of Microsoft Office Products, including Word, Excel, Power Point, Access and Visio. Project Planning skills are essential
Strong working knowledge of ISO Quality Management Systems Standards
Ability to direct and manage team members with day to day activities as well as special projects to assure timely completion

Senior Quality Manager Resume Examples & Samples

Lead in the development, improvement or maintenance of compliance requirements supporting corrective activities, PAI readiness, and government agencies (FDA) inspection management
Participate and lead in internal/external audit and inspection preparation and management. Manage remediation projects, leading cross-functional teams. Manage various source observations (audit, inspection, risk assessment) to assure corrective actions are implemented
Ensure that the internal audit processes are conducted and that the corrective actions are implemented
Develop government agency communications, including written correspondence, responses to inspection observations, presentations and verbal communication including but not limited to Escalations and Field Alert Reports
Support the implementation and tracking of Key Quality Indicators
Lead the creation and maintenance of the annual Quality Plan
Facilitate with close interaction with the local, region and global QA functions, product quality investigations processes related to Field Alerts, Product Recall, Counterfeit and/or Withdrawals
Facilitates the Deviation and Change Control Governance process at the site
Actively manages the Compliance team and sets up their development and objective targets
1) Thorough knowledge of applicable procedures, specifications, regulations and standards. 2) Ability to manage/supervise a large team of employees 3) Strong analytical and problem solving skills. 4) Strong communication and leadership skills. 5) Strong interpersonal/communication/influencing/negotiation skills 6) Strong project management skills. 7) BS in science or engineering; advanced degree helpful. 8) 7 years in Quality, Manufacturing, 9) Engineering or related field. 5 years of management experience

Senior Quality Manager Resume Examples & Samples

Promote and maintain effective communications and relations with district management, project management teams, authorized inspectors and engineer or client as required
Recruit, hire, train, mentor and supervise district and project quality control inspectors
Assist project teams in setting up the quality department and preparing for project kick-off and pre-job planning meetings. Assist in identifying the proper Inspection and Test Plans (ITP’s), checklists, and other documentation for the project
Update the American Society of Mechanical Engineers (ASME) Quality Control Manual at least annually as required by code revisions, lessons learned, best practices, corporate initiatives, or changes in the work practices in the field
Support project teams in the development and implementation of project quality plans and supplemental procedures as needed
Oversee code compliance for work which falls under the ASME Quality Control Manual
Bachelor’s or Master’s degree in mechanical, electrical, welding, civil engineering or construction management/engineering is preferred
Certifications from AWS, CWB, API, ACI, ICBO, ASNT, NACE, etc. are advantageous
Exceptional math, computer, verbal and written communication skills; proficient with Microsoft Office Suite
Ability to freely access all points of a construction site in wide-ranging climates and environments

Senior Quality Manager Resume Examples & Samples

Serve as People Manager with strong leadership skills
Project Management / Continuous Improvement
Experience providing QA support and oversight of GMP manufacturing operation including batch release
Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting
O o cGMP’s and associated CMC regulatory considerations

Senior Quality Manager Resume Examples & Samples

Lead the Quality Engineering group primarily responsible with providing quality oversight and support to the Annex Drug Product Facility operation in the following key areas/activities; engineering, validation/qualification and facilities and utilities support
Provides change control assessments and approval relative to product quality. Chair the weekly change control review board meeting. Support investigations and CAPA for deviations within areas of responsibility. Collaborate with customer groups (Manufacturing Operations, Formulation Development, Analytical Development, and Facility Operations) to ensure quality systems are monitored and established metrics are met
Provide quality oversight of site validation activities including qualification of manufacturing equipment and control systems, facilities and utilities system, and analytical instrument,
Provide quality oversight of various site wide programs including the equipment and facilities maintenance, instrument calibration, periodic assessment, environmental and utilities monitoring, stability chambers trending, and SCADA alarm management
Provide support of facilities and engineering projects, including capital projects, annual plant shutdown, and various improvement projects as assigned
Responsible for tracking QA-Eng performance metrics; including site metrics for change control
Participate in inspection readiness activities and provide support during regulatory site inspections. Lead compliance walkthroughs of the site and help drive the closure of any observations
Lead/participate in continuous improvements of department processes
May be required to assist the QA GMP Operations group with commercial and clinical batch disposition activities
Strong leadership skills with the ability to thrive in a high throughput environment
Ability to lead and manage complex projects/teams within corporate objectives and project timelines
Ability to independently lead cross-functional teams, represent the Quality unit
Ability to evaluate quality matters and make decisions utilizing risk based approach
Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices. Strong validation background
May serve as People Manager
M.S (or equivalent degree) and 4-5 years of relevant work experience, or B.S in scientific or allied health field (or equivalent degree) and 9+years of relevant work experience
Experience providing QA support and oversight of GMP manufacturing operation

Senior Quality Manager Resume Examples & Samples

Quality KPI (Scorecard / Satisfaction) reporting globally to stakeholders in China, other regions and HQ
Support the Risk assessments and decision competence with Business Division
Installation and definition of effective process flow for complaint management in China
Manage and control spending within budget

Senior Quality Manager Resume Examples & Samples

Use effective verbal and written communication skills. Add, subtract, multiply and divide whole numbers and fractions rapidly and accurately
Read and understand plans and specifications. Visualize two-dimensional drawings in three dimensions
Examine/inspect field conditions and identify problems, inaccuracies, and cost saving measures that arise or that may be encountered. Take corrective actions as needed
Inspect subordinates’ work for compliance with the contract plans and specifications, point out deficiencies and explain and take any corrective action needed
Listen to other employee's and supervisor's suggestions, complaints, problems, safety concerns and recommendations, evaluate each and then devise and implement a plan of action based on that evaluation
Observe functioning of installed equipment or systems to determine hazards and need for adjustments, relocation or replacement
Identify safety hazards you or other employees may be subject to and take all necessary corrective actions to eliminate or minimize hazards
Understand and respond appropriately to all safety hazards and warning devices (i.e. back-up alarms, smell of smoke, different colored warning tags, warning sirens.)
Understand and implement lockout/tagout procedures in safe manner
Be motivated and work productively
Have a thorough knowledge of the District’s Quality Management System, Work Instructions and Procedures
Develop the Project Quality Plan, goals and objectives. Identify project level risks and implement measures to limit liabilities
Develop a complete understanding of contract, specifications, applicable codes and jurisdictional requirements and client quality expectations
Promote and maintain effective communications and relations (verbally and in writing and through periodic management meetings) with District management, project management teams, and the engineer/client as required. Conduct and coordinate client interviews and surveys
Develop future leaders by mentoring and coaching quality personnel. Hire, train, mentor and supervise project quality personnel and provide input on compensation
Coordinate Quality staffing needs on the project with the District Quality Manager and assign qualified personnel
Manage implementation and effectiveness of the Project Quality Plan through periodic reviews, document findings and implement corrective/preventive actions
Facilitate quality walk-arounds (tours) and quality plan implementation reviews (surveys/self-assessments) to status the program effectiveness
Ensure that tests are performed, received and interpreted timely so that impacts due to failure are minimized. Review/approve (initial/date) all third party test results for compliance with project requirements
Provide training to supervision and craft/trades regarding the project specific quality process and requirements
When required, develop written plans and procedures for project specific activities to supplement task planning, i.e. pipe line cleaning
When required, assist in the development and implementation of the Turnover Package Procedure and assist in assembling turnover packages
Manage Non-Conformance reporting. Ensure the cost of rework is tracked and reported
Be familiar with District’s ASME Quality Control Manual; be capable of managing the ASME Quality Control Inspector’s work on the assigned project including Pre and Post Weld Heat Treat (PWHT) activities
Research and answer questions of a technical nature. Assist in the interpretation of construction codes and standards
Coordinate with the District for needed codes, standards and procedures, including Welding Procedure Specifications
Ensure that welder certifications and status logs are maintained current and submitted as required
Provide input on continuous improvement of District’s quality program
If assigned, oversee QA/QC on multiple projects
Perform all other job-related duties as requested by supervisor

Senior Quality Manager Resume Examples & Samples

You are responsible for leading, planning, and implementing quality management support projects to ensure regulatory compliance and improve competitiveness of Siemens Healthineers businesses worldwide (Business Areas, Business Lines, Key functions and Countries)
You will provide solution oriented and practical support of the Siemens Healthineers units in the implementation of national and international requirements (standards, laws, regulations) in their QM systems and processes
You will identify trends and focus topics to use as an input for knowledge sharing sessions to ensure dissemination of best practices and lessons learned throughout Siemens Healthineers
You will lead, plan, and execute healthcare regulatory compliance audits on a global scale
You are responsible for the definition and maintenance of process descriptions, quality regulations, and requirements
You will create content and perform training sessions on quality relevant topics
You hold a master‘s degree in science or a comparable subject (e.g. Chemistry, Biomedical, Hardware or Software engineering) – alternatively you have a comparable professional experience
You have 7-10 years of relevant experience in Medical Device industry (in-Vitro and/or In-Vivo) in the field of Quality Management
You have expert knowledge of standards and requirements in the area of software development in medical engineering in accordance with IEC 62304 and FDA Software Validation Guidance
You have several years of hands-on quality auditing experience (ISO 19011 or similar certification desired)
You have advanced knowledge in continuous improvement methods and processes (e.g. CAPA) as well as knowledge in risk management in accordance with ISO 14971
You have fluent written and verbal communication skills in German and English as well as strong communication and presentation skills
On a personal level you exhibit customer oriented behavior, high motivation and initiative, you are creative, proactive and assertive with strong leadership skills

Senior Quality Manager Resume Examples & Samples

Provides necessary definition, development, and deployment of product/package quality assurance strategy by addressing all phases of product development from water quality and injection molding to the finished package
Aid in the development, publishing, and/or maintenance of all Niagara Bottling Quality Assurance procedures, policies, and standards in use at each designated production location
Coordinate the development and/or implementation of Niagara Quality Assurance SOPs, policies, and standards through the appropriate corporate personnel within Niagara Bottling
Ensure that all in-house Quality Assurance standard operating procedures (SOPs), policies, and standards are written and/or published with the intent of assuring that all finished products meet and/or exceed the product/packaging standards as set forth by Niagara Bottling, FDA, local state requirements, and the IBWA (bottled water only)
Ensure all designated production locations maintain all required regulatory information and certifications. (i.e. kosher certificates, SQF certificates, 3rd party audits, etc)
Ensure all in-house bottled water, beverage analyses, laboratory tests, and procedures are properly understood and carried out. When required by a customer, ensure that relative/routine quality and production documents are forwarded to the customer in a timely manner
Review chemical usage, storage, and safety practices with each designated production locations
Work with each designated production locations to ensure water processing, batching, thermal processing, bottling, packaging and logistics quality compliance. Ensure compliance and improvement through GMP auditing and implementation of corrective actions
Maintain a strong knowledge of food processing and plant sanitation principles and techniques
When necessary, monitor the product/package quality as well as GMPs at regional 3PL warehouses and or re-packs

Senior Quality Manager Resume Examples & Samples

Develop a strong quality team to improve customer satisfaction and quality objectives. Acts as quality interface for all customers, implementing customer specific quality requirements and assuring conformance
Responsible for planning, leading, educating and assisting the site staff in the execution of the established continuous improvement strategy through recommendation and strategic implementation of metrics, tools and training
Instills a disciplined approach to seek out and eliminate quality problems at all levels of the organization, achieved through a sustained, results-oriented process to instill this culture changing mindset into all levels of the organization through leadership, tools, metrics and training
Defines a road map of continuous improvement for the organization by establishing priorities, methods and strategies for implementation using data to both guide the process as well as monitor the result
Analyzes failures, determines cause, determines responsibility, and initiates corrective action
Implements Advanced Quality Planning in new product development process, participates in program and design reviews
Utilize quality system performance KPI to drive performance improvement
Promotes quality achievement and performance improvement across the organisation
Ensuring compliance with national and international standards
Other duties as assigned – it is understood that this list of major duties and responsibilities is not an inclusive list and that other duties and responsibilities, which may include helping others in the same or different departments, may be assigned by supervision
Have an absolute commitment to and passion for achieving Quality improvements in a made to order technical product focused environment
Have a high energy level and drive required to lead critical functional areas within a dynamic business unit
Have strong persuasive skills and the ability to exercise influence beyond direct authority
Have a hands-on style and a willingness to perform a range of detail-level work, i.e. a doer rather than an administrator
Ability to teach and train others
Demonstrated leadership and facilitation skills in a matrix environment and ability to motivate all levels of the organization. Excellent oral and written communication skills, to include presentation skills and facilitation of groups toward deliverables
Troubleshooting and Complex Problem Solving with ability to evaluate options and implement solutions
Ability to link customer needs and business processes; Deductive Reasoning (the ability to apply general rules to specific problems to produce answers that make sense); Inductive Reasoning (the ability to combine pieces of information to form general rules or conclusions, includes finding a relationship among seemingly unrelated events
Extensive conceptual and analytical ability in order to conceive quality requirements in designs, production operations and processes
Ability to manage multiple projects and adapt to changing priorities
Ability to establish and maintain effective working relations with a wide variety of individuals
Ability to represent the company in a positive and professional manner
Minimum of 3 years experience as Senior Quality Manager
Certification is an advantage including Quality Improvement Associate, Six Sigma
Knowledge of tools, concepts and methodologies of QA and relevant regulatory requirements

Senior Quality Manager Development Projects Resume Examples & Samples

Manages all quality aspects at external manufacturers for Drug Product and Medical Devices of Biopharmaceuticals, particularly for late stage development phases (product transfer, process validation, dossier submission)
Ensures the operational business complies with international standards of cGMP, regulatory as well as internal requirements
Single point of contact for all quality related activities at the contract manufacturer and within the Novartis Contract Manufacturing Relationship Team
Ensures pre-approval inspection (PAI) readiness and drives remediation efforts to ensure sustained quality performance and reliable supply of products

Senior Quality Manager Resume Examples & Samples

Interact with SSPA stakeholders at multiple levels to define and deliver solutions to establish quality standards and processes
Remain flexible to changing priorities, open to new ideas and have relevance and moderation quality as the top focus
Can think big and develop new ideas, simultaneously well at nurturing new ideas and applying high standards to weed out those that are least valuable
Is comfortable collaborating and influencing team members, working with engineering teams and other business groups, and presenting projects to senior leadership on a regular basis
Has the technical aptitude to quickly grasp complex technical issues and communicate directly with technical teams
5-7 years project/program management /Quality Assurance or Lean 6-Sigma is required
Bachelor’s degree in business discipline
Experience developing operational process and technologies to drive quality and continuous improvement
Experience in customer experience and quality initiatives
Map business requirements, understand business process, study and analyze workflows, design solutions and communicating results throughout the organization
Proficient with MS Excel / MS office
MBA is preferred
Good oral and written communication skills are crucial
Experience in online retail is a plus
Ability to think and act both strategically and tactically
Proven track record of taking ownership and driving results in an fast paced business environment
Demonstrated ability to build quantitative reporting and dashboards for defect analysis
Curiosity to dig several layers deep into metrics, have an innate desire to understand key drivers and whether they are the correct or best metrics to measure/manage a business or process
Experience in managing people
Innovative and self-directed

Senior Quality Manager Resume Examples & Samples

Participate in weekly communications meeting with the safety team (regional and global safety leads) including reporting out on active issues and new issue tracking through the PPIRP system
Participates in the Structures Weekly Quality call to ensure understanding and escalation of any potential Safety Compliance issues
Leads all identified Structures Safety and Compliance concerns through the verification and documentation phases
Leads and confirms all identified Structures Safety Compliance related read across and lessons learned activity through the verification, documentation and implementation phases
Assist in the development and review of white paper summaries for each identified issue and distributes them as determined by the concern escalation and notification protocols
Assist in timely issue closure through the PPIRP system as defined and agreed upon in the problem solving process
Review and sign-off that all necessary Engineering Specifications and Testing/Inspection Instructions to prove compliance to identified Safety and Compliance Standards are included in the DV, PV, and IP mandated sampling frequencies. 100% compliance is required
Complete documented Safety and Compliance check sheet to confirm that all applicable program standards and associated controls have been developed for the product. Document shall be signed by all Advance program functions and provided to the Structures APQP Manager for attachment to APQP profile record. 100% compliance is required
Minimum of 7 years of Experience in Automotive Product, Advance Manufacturing Engineering or Automotive Quality Manager position
Strong Systems or validation background in Seat Systems Structures highly preferred
Strong Welding background and testing knowledge for Automotive Structures highly preferred

Senior Quality Manager Resume Examples & Samples

Implement and supervise technical quality (i.e., adherence to client, regulatory agency, and company requirements), perform administrative functions (i.e., budgeting, forecasting, staffing, etc.), and help to maintain harmonious client relations
Serve as project Quality Manager on medium to large projects, if necessary
Serve as the office Quality Manager, if necessary
Facilitate the implementation of the Operating System Requirements (OSR) in offices for which responsibility is allocated
Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders
Ability to attend to detail and work in a time-conscious and time-effective manner

Senior Quality Manager Resume Examples & Samples

Minimum of 7 years of experience in Automotive Product, Advance Manufacturing Engineering or Automotive Manager position
Strong Systems or validation background in Automotive components highly preferred
Participates in the JIT Weekly Quality call to ensure understanding and escalation of any potential Safety Compliance issues
Leads all identified JIT Safety and Compliance concerns through the verification and documentation phases
Leads and confirms all identified JIT Safety Compliance related read across and lessons learned activity through the verification, documentation and implementation phases
Complete documented Safety and Compliance reviews to confirm that all applicable program standards and associated controls have been developed for the product. Should be confirmed in MGR reviews to complete the APQP requirements for each program phase. 100% compliance is required

Senior Quality Manager Resume Examples & Samples

Leading the roll out of Global NGP quality standards and manage the ongoing performance and quality requirements of end markets in Geographies
Leading delivery of NGPs on Geography level in scope of quality work streams. In this context, the role holder contributes to the way quality is integrated into each new product implementation project
Manage and cooperate with Global, Regional and local stakeholders for the sign off of new product introductions and assessment of process capability in order to enable a smooth transition into local production and launches
Deputy of NGP Quality Manager during TR/TA
Responsibility for supporting the deployment of processes and systems needed to measure and report quality performance in the end markets. This includes the support to design, develop and embed end to end customer care processes aligned to global strategy while managing local uniqueness (i.e. call center, device & consumable retrieval process, device hyper care service)
Manage the collation of region wide quality information such as quality data from NGP factories and consumer complaints from end markets, to ensure timely publication to the Global NGP team & senior management and other key stakeholders
Ensure that information is reliable and up to date and escalate deviations from agreed reporting performance levels to the Geographic Quality Manager and appropriate business recipients
Applies advanced quality planning tools (FMEA, DOE) for development and qualification of new materials and products and builds the quality plan for each innovation or NGP within the Geography
Responsibility for maintaining external testing facilities within the region to support ongoing quality compliance measurement (where required) and root cause analysis of major quality incidents

Senior Quality Manager Resume Examples & Samples

Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory Current Good Practice guidelines, health authority guidance, Standard Operating Procedures, Health, Safety & Environment, etc). Promote and enforce compliance to guidelines. If managing associates, ensure same for them
Act as counterpart for Technical Development Quality organization for new products entering the site
Write/contribute to internal compliance policy and/or comment to regulations
Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process
At least 5 years of relevant experience in Quality Function
At least 3 years in a commercial manufacturing site
Ability to influence people, negotiate and communicate
Sound scientific, technical and regulatory knowledge in a specific area
Excellent knowledge of Current Good Practices, working knowledge of safety and environmental regulations and guidelines
Good and proven ability to analyze and evaluate Current Good Practice compliance

Senior Quality Manager Resume Examples & Samples

Establishing and maintaining metric capture programs, trending activities and implementing the QC plan
Conducting and leading internal and external meetings and interfacing with customers
Providing strategic support at a branch location level
Performing corrective action investigations, determining root causes and defining corrective/preventive action measures
Performing internal audits
Performing training and supervising of the inspection workforce
Evaluate and update current inspection and system procedures
Perform Qualification tests on work benches
Set up and participate in QAT''s and meetings
Manage the Quality Information Systems (QIS)
Conduct customer on-site visits
Train new and current employees
Initiate and manage new projects
Provide strategic direction to take CTDI Quality to the next level
Strong understanding and experience of TL9000 and/or ISO 9001 Quality standards
Expertise involving electronic equipment, diagnostics, and/or electronics repair
Working knowledge of IPC-610 and its application to process control
Strong documentation keeping best practices
Excellent analytical skills, organizational skills, and follow-up skills
Ability to create and deliver presentations
Must be able to communicate with all levels of management
Must be detail oriented and a team player
Ability to read electronic and electrical schematics and machine shop drawings
Ability to motivate production/quality performances

Senior Quality Manager Resume Examples & Samples

Collaborates with other functional managers in planning and implementing quality programs to ensure a customer perception of trust and reliability
Establishes quality policies that ensure compliance at the lowest possible cost
Reviews external complaints for the purpose of developing appropriate quality policies and standards
Manages and executes quality programs that lead to improvements in quality, costs and overall efficiency
Proactively advises management regarding the overall quality standard of products
Effectively represent theNorth Carolinaplant to the customer through customer visits, visits to customer locations, during customer surveys and through problem resolution
Monitors quality indicators and trends and makes this information available to the operating units
Partners with engineering and marketing as required for effective product introduction and problem resolution
Provide overall direction for the vendor quality program and incoming inspection of purchased material
Monitor and stay abreast of customer requirements to assure they are integrated into the Fletcher Quality system
Provide overall direction for warranty analysis and subsequent corrective action
Prepare budgets and monitor performance to plan
Identify capital requirements as they relate to items that could affect product quality
Provide overall guidance for the gage control system
Benchmark other organizations as well as other BorgWarner facilities for activities and systems that could assist in achieving world-class status
Champion the Company Quality Award activities
Manages TS 16949 activities and subsequent registration
Provide guidance where required to assure successful application of Production Part Approval Process
Participate in the deviation process to assure product quality is not adversely affected
Participate in design reviews
Acts as an integral member of the supplier performance improvement team along with the Materials Manager
Represents the Fletcher plant and the Division at Corporate sponsored and mandated quality improvement initiatives
Lead the management review process to evaluate the effectiveness of the Quality System
B S Degree Engineering MUST HAVE AN ENGINEERING DEGREE
Six Sigma Black Belt – strongly preferred
5+ years experience as a Quality Manager and Operation Management Experience in a fast paced manufacturing environment with full responsibilities of internal, external and customer quality (automotive strongly preferred)
Operation Management Experience

Senior Quality Manager Resume Examples & Samples

5 years Experience
Bachelor's Degree in Food Sciences
Able to Relocate
Knowledge of SAP systems
Good written, verbal and computer skills

Senior Quality Manager Resume Examples & Samples

Bachelor's Degree in Food Science or related field and/or training
Food Engineer with 5 years' experience on industrial sites strongly preferred
Knowledge of regulatory databases and applying to building and equipment for products in the USA (3A, USDA, FDA norms)
Basic working knowledge of food microbiology
Good knowledge of audit methods and quality improvement tools (Statistics)

Senior Quality Manager Resume Examples & Samples

Excellent knowledge of Current Good Manufacturing Practice working knowledge of safety and environmental regulations and guidelines
Good knowledge of drug development. Novartis - Job details Page 1 of 2 https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&si teid=5261... 09.03.2016 6. Good organizational skills
Good and proven ability to analyze and evaluate Good Manufacturing Practice compliance

Senior Quality Manager Resume Examples & Samples

Formulates and executes quality assurance objectives in alignment with Corporate, Business Unit, Plant goals and requirements. Coordinates objectives in collaboration with the plant manager to maximize product performance, reliability and minimize costs
Performs Gap Analysis between established goals and objectives and evaluates current plant QA capability. Develops and communicates plans to close critical QA gaps
Sets clear goals and performance expectations for all direct reports, continuously assesses the performance and capabilities of all QA direct reports (relative to goals and future business requirements) and provides them feedback and holds them accountable for excellent performance
Develops, analyzes and reports statistical data relative to quality systems performance and implementation ensuring customer expectations are maintained
Develops and maintains audit functions ensuring quality systems and products are consistent with internal documentation, standards, regulatory agencies and customer requirements
Drives corrective and preventive action processes ensuring full identification of issues, root cause analysis and validation ensuring quality systems are effective
Provides documentation systems that establish an accurate baseline of design specifications, component/product drawings, and manufacturing processes
Develops and maintains failure analysis process; ensures feedback and corrective action communication and implementation is consistent with customer expectations
Directs employees engaged in inspection and testing activities to ensure continual and effective control over materials, facilities, processes and products
Acts as Plant Management representative and ensures full compliance to ISO 9000, ISO 13485, 21CFR 210-211, 21CFR820 and EQOS standards as applicable to the site
Bachelor’s Degree in relevant field; minimum of 10 years quality management experience in a progressive quality environment
Successful experience working within a Life Science progressive manufacturing environment
Expertise implementing Six Sigma, Statistical Process Controls, FMEA, process audits and other proactive quality management practices
Strong management and leadership skills with an ability to collaborate with manufacturing, R & D, Product management, Process Engineering and all other organizations
Experience with SAP desired
ASQ Certified Quality Manager or Auditor preferred
Lean manufacturing certification/ experience highly desirable
Experience leading a quality organization in the pharmaceutical or biopharmaceutical industry is desired

Senior Quality Manager Resume Examples & Samples

Manages all personnel, activities, initiatives and site specific programs in the achievement of quality organizational goals, as well as Corporate driven initiatives related to the Quality System in support of the following services - incoming inspection, product release, material review, ship hold, field action, product complaints, RTM, SAP Quality Module, Quality Control inspection processes, process control & development and project management; Interfaces with other members of Management with respect to regulatory compliance initiatives, on-going compliance with all procedures and standards, as well as implementing continuous improvements initiatives; Sets policy and procedures for the Quality processes at the European Centre of Operations, in conjunction with the Director Quality Assurance, including systems which impact the European Distribution Centre from other BSC facilities. Responsible for interacting with internal BSC sites and external customers on Quality related issues; Provides vision and leadership for strategic projects with significant impact within the site and Corporation; Works collaboratively across functions, regions and business units to implement project strategies and tactical plans to deliver results; Contributes to organizational efficiencies through the recommendations regarding the creation, implementation and harmonization of new corporate standards and procedures; Acts as Subject Matter Expert in internal and external audits
Quality Compliance: Ensures the Quality System is substantially compliant to GMP/QSR practices and standards as defined by the FDA, ISO and regulatory bodies in close coordination with the Quality Systems Manager. Works with Senior Management to identify areas of the quality system needing improvement. Takes a leadership role in developing and implementing new techniques and initiatives to enhance the quality management system on site; Maintains site compliance to external standards
Quality Metrics & Communications: Develops and generates quality metrics reporting/tools as well as process improvements. Responsible for trending/analysis of any Quality data and develops/ maintains SOPs for recording, evaluation and reporting of Quality and reliability data. Shares periodic information across the Regional Quality Team on local issues, with the purpose of soliciting input on best practices and/or seeking consistent solutions to common problems; Provides the local management team with periodic reports on appropriate quality metrics; Establishes cross-functional team relationships; Where applicable, establishes and fosters relationships with local medical device industry groups to advance the interests of Boston Scientific in matters of quality and compliance
B.S. Degree with minimum of 9 years’ experience in quality for medical devices and/or pharmaceuticals
Demonstrated leadership & people management experience within a functional management role
Comprehensive understanding of the QSR, cGMP and ISO/MDD standards
Excellent communication skills with the ability to influence others
High level of initiative & autonomy through continuous questioning of current practices
Strong command of the English language (verbal & written)
Effective team member, motivated to achieve and demonstrate best practices in line with the department & global objectives

Senior Quality Manager Resume Examples & Samples

Develop and drive initiatives to improve and sustain manufacturing quality across all manufacturing locations, including third party locations
Drive continuous improvement workstreams in support of product quality, customer experience, delivery and cost initiatives
Directly partner with the other functions to improve customer satisfaction and drive customer loyalty
Develop effective Quality Systems and deploy across all manufacturing sites. Establish sound process to ensure robustness of system
Partner with business leadership to deploy customer scorecards across all manufacturing sites driving continuous improvement, connectivity to customers and enabling certifications
Establish effective root cause corrective action and failure mode analysis processes and tools to drive effective mistake proofing and failure mode elimination
Establish cross functional quality continuous improvement teams to drive complex problem resolution and set proactive activities to address problem statements
Drive RMA and CA cycle time down and improve on response time
Responsible for all site quality certifications and product validation plans
Sets effective process and product audit programs to ensure exposure is limited and that quality aspect of product is in control
Create and implement short and long term vision for manufacturing quality, centered on the customer and the built in quality strategy
Creates development plans for all quality leadership employees setting up sound and robust succession plans and career paths
Provide leadership, guidance and coaching to site leads and site quality teams in performing effective customer response and communication on quality and manufacturing related topics
Directly responsible for all business quality metrics as well as all customer scorecards and certifications
Partners with Technology to effectively launch products in line with launch protocols and processes and that meet customer specifications
Establish COA’s which effectively represent requirements that are specified and measured for the end use application and/or the end-use customer
Develop and deploy effective processes to ensure incoming raw materials meet proper specifications based on the end use application or customer
Bachelors of Science Degree in Engineering or Technical discipline
Minimum of10 years in field or an advanced degree and comparable experience
Minimum 10 years quality, service or manufacturing experience
Master’s degree in business is preferred
Process oriented and customer focused
Results driven with a positive can-do attitude
Communicate effectively across multiple layers of the organization
Excellent collaboration and negotiation skills
Strong strategic and business Acumen
Ability to foster teamwork
Leadership skills including communication skills, mentoring and constructive feedback
Ability to work collaboratively with cross functional
Six Sigma / DFSS background, strong analytical skills and problem solving skills
Must be capable of supervising direct reports in multiple locations
Strong computer skills, particularly Excel or Access for data-mining and report generation, including Pivot charts & tables
Ability to get Green Belt certified (After Hire)
Trained/certified in Six Sigma and/or Lean Manufacturing techniques. Green Belt or Black Belt Certification highly desired
Certified Quality Engineer by American Society for Quality (ASQ)
Expert in quality management tools such as APQP, PPAP, FMEA, MSA, SPC
Familiarity with Quality Systems (e.g., AS9100, ISO 9001, etc.), Lean Manufacturing, Manufacturing Process Control, Six Sigma

Senior Quality Manager / Engineering Resume Examples & Samples

Provide Quality Systems leadership using recognized standards as the basis for process development and optimization, procedure development, data collection, and Quality Systems training
Develops and maintains the Program Quality policy, processes, procedures, and related documents. Reviews Quality Manuals, documents and implementation procedures to verify compliance with industry codes and standards, and regulations
Participates in Client Quality planning and preparation meetings
Plans and executes required audit activities (schedules, reports, finding resolutions). Facilitates all internal and external Quality audits and briefs management with results
Work closely with the Program Management to develop, implement, and manage the Quality Program for the Client, including design and construction phases of each element, as well as program-wide activities
Manage the Program Quality Management team for each element during mobilization, implementation, and closeout phases
Develop and manage quality training program
Manage the Quality team in the oversight of developers/contractors' quality programs for each element via the following
Proficient with CMAR, design build, and traditional project delivery methods; in depth knowledge of the contracting relationships and typical contracting terms between the general contractor and all other parties
Thorough knowledge of engineering principles and disciplines, construction technologies and job site construction management and OSHA
Knowledge of scheduling and familiarity with project and document management software (such as Primavera, PROLOG, Expedition, etc.)
Demonstrated ability to read and interpret civil, structural, and site utilities plans and detailed shop drawings
Bachelors in engineering, construction or related field

Senior Quality Manager Resume Examples & Samples

Provides oversight of inspection activity for product throughout production cycle. Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products in order to maintain compliance with all applicable codes, standards and/or specifications as well as all corporate and quality policies
Responsible for all QA/QC functions and reporting including the following processes: Non-conformance (NCR); Corrective/Preventive action (CPAR); Field quality reports and customer complaints/returns; supplier monitoring, auditing and evaluation; gage calibration; quality inspection plans and contract packets( quality records); Material review board; Warranty analysis and investigations; Cost of Poor Quality reduction; first article qualification and production approval; and auditing ( internal and external). Plan and Conduct monthly Quality Management Reviews
Oversee the process for design, release, and revision control to manufacturing and make suggestions to Engineering on necessary changes to reduce cost and assure consistent quality
Direct the efforts and activities of Quality Assurance Team to ensure support to the shop floor and related suppliers, and contribute to the ongoing improvement of productivity and quality while reducing costs of operations for assigned processes
Lead the quality program including establishment of required procedures, work instructions, and forms, internal audits, corrective action, and outside audits in meeting certification to recognized standards. Responsible for establishing and maintenance of 3rd party certification such ASME U-Stamp, China Code and other international standards
Assure that compliance with established quality standards by all internal operating functions and external suppliers is attained
Assist in the pre-quotation review of customer quality specifications to assure that any special requirements can be met and that adequate cycle time and cost is reflected
Establish and maintain sound procedures to ensure the definition of proper quality standards and the means of measuring conformance to those standards
Review internal and external failure costs and develops effective corrective/preventive action programs to reduce defect generation and associated costs
Supervise the training, development and effectiveness of the quality group, while maintaining a safe operation and positive employee relations
The Manager, Quality has an overall responsibility for developing, communicating, measuring and enforcing the Quality Policy through the establishment and monitoring of consistent work processes that fully meet internal and external quality requirements
The incumbent is responsible for determining the frequency and detail of in-process quality audits so as to maintain cost effective processes and products that meet customer expectations and specifications. Establishes quality processes and procedures and publishes required internal and external quality documentation
This position is responsible, in coordination with Sourcing group, for establishing vendor qualifications, and interfacing with such vendors to assure a clear understanding of and full compliance with required quality standards,
Responsible for assuring that contract quality procedures and documentation requirements are met. This includes responsibility for assisting the Product Managers in reviewing customer quality specifications and attending customer meetings to achieve agreement on specific quality requirements. In this effort, consideration shall include the Division's design and production capabilities as well as schedule and cost impacts
Responsibility for quality shall include units installed in the field. Maintain communication regarding problems and solutions between Manufacturing, Engineering, and the Service groups. In the event of repetitive or major field problems, provide leadership in warranty analysis and corrective action and visit customer sites as required for fact gathering
The manager is responsible for managing the budget and all quality resources in meeting division goals
7 + years’ experience in a quality function within a manufacturing environment with progressing levels of responsibility
Two plus years in quality assurance with working knowledge of quality systems, such as ISO
Quality Management System Development
Recognize industry standards and codes such as ASME Section VIII
Experience managing a quality organization with multiple sites
Ability to manage in a matrixed organization
Experience with Oracle ERP/ QMS
Lean/Six Sigma
Demonstrated Leadership Ability
Leading a team of 5 - 10 + direct reports
Assertive
Team Oriented, ability to motivate others
Ability to make data based decisions in a timely manner
Customer Focused mindset
Strong interpersonal skills, with the ability to interact with all levels of the organization
Strong Technical/ Analytical Skills
Data-driven problem solving capacity (DMAIC, RCCA, etc.)
Ability to analyze and manage operating expense to business expectations
Ability to build and manage annual budgets (headcount, capital, and all related operating expenses)
Demonstrated Communication Skills
Reports
Training

Senior Quality Manager Resume Examples & Samples

Bachelor's Degree in Science, Engineering or Technical field
Pharmaceutical, biologics, and/or medical device experience
Knowledgeable in FDA/QSR requirements and quality system development/management
Previous experience mentoring and managing a team of professionals
Experience with managing external agency audits
Experience with product and process validations in the pharmaceutical/medical device industry
Strong technical skills in the manufacturing of solid oral dose, semi-solids, devices, and biologics
Demonstrated project management and leadership skills
Training and experience in statistics (DOE, SPC)
Lead auditor certification
Training in problem solving techniques or Lean Six Sigma Green belt
Training in coaching and management skills

Senior Quality Manager Resume Examples & Samples

Manage a team of quality program managers building and improvement the data transformation quality processes
Develop and execute against a quality strategy for delivering the highest quality data products
Understand how all elements of the data transformation system work together and develop data drive quality approaches that fit the overall strategy
Be responsible for development of improvement strategies with defined measurable metrics to gauge success
Provide clear and concise quality assessments of data products from full data sets of test results
Drive the team to build a Zero Defect culture by managing controllable root-cause defects and ensure implementation of controls and minimize losses
Interact with stakeholders at multiple levels and dynamically quality teams to define and deliver solutions to establish quality standards and processes
Disseminate project information to stakeholders and senior management
Work with Customer and Operations teams to understand data and quality needs
Set directions/goals for a team of Quality program managers
Verify Quality Metrics in place and meet goals, trigger containment actions and corrective actions as appropriate
Lead and support problem solving activities for Quality Alert as well as any other quality issues
As a Sr. Manager Quality Engineering, on a day-to-day basis, you will lead a global organization of close-knit Quality Program Managers (multiple locations) that are incredibly data driven, quality obsessed, and highly collaborative
You'll drive exciting Quality Improvement programs that set the standard for Quality across operations teams, drive automation efforts across various programs that become industry best practices
You will also find yourself partnering across organizations with world-class technical leaders, Engineers, Research Scientists, Best in class operations leaders, and Data Analysts who have expertise in a wide range of disciplines
As Quality Managers on our team we’d love to break things to see how they work, improve on what works, discard what doesn't, and learn from both. We do all of this using data driven approaches that measure quality of our services, processes and tools that enforce automation
Establish quality standards by role, region and vertical. Engage data engineering and analytics to deliver automated solutions, where possible
Work closely with Workforce, Analytics, Data Engineering, and Software Engineering teams to drive initiatives on Operational efficiency
Bachelors or Masters in ME/IE/EE/CS, Systems engineering, or related Engineering degree
Strong quality management credentials, with at least 5 years of experience managing teams, ideally with hands-on quality improvement experience
At least three years of managing teams
Hands-on experience with Quality engineering efforts focused on operations execution, planning, execution and designing, implementing and maintaining high quality processes
Experience building customer facing quality services
Ideal candidates must be innovative, creative, flexible and self-motivated, with the ability to design and implement high-performance, reliable, and measurable quality programs
Strong understanding of process improvement techniques in a production environment
Strong understanding and demonstrated success with practical applications of Lean / Six Sigma tools such as Failure Mode & Effects Analysis, Design of Experiments, Measurement System Analysis, Analysis of Variance, Hypothesis Testing, Value Stream Mapping, Pareto Charts, Gage Repeatability & Reproducibility, Cpk
Must be able to multi-task setting priorities in-line with business needs
Team work spirit
Preferred 7+ years of working experience in engineering and/or quality role with 5+ years in a quality environment

Senior Quality Manager Resume Examples & Samples

Leverages the efforts of the quality and manufacturing teams thru process improvement tools to reduce variation in operation. The incumbent will be a recognized expert for Structured Problem Solving, Process Controls tools required to drive the continuous improvement culture into the organization
Reviews test procedures (functional, acceptance/qualification) for completeness with regard to technical content, test equipment and test data; provide assistance to inspection test stations. The Senior Quality Manager will resolve quality problems with Crane Aerospace suppliers by leading and managing the Supplier Quality Engineering staff
Implement Advanced Quality Planning in new product development process, participates in program and design reviews, implement PPAP where required and assure that product quality objectives are met
Maintain a Quality management System in compliance with FAA, EASA, AS9100 and government regulatory compliance

Senior Quality Manager Resume Examples & Samples

Reviews charts and analyzes clinical record documentation
Conducts ongoing activities which monitor established quality of care standards in the participating provider network and for other clinical staff
Collects, analyzes and prepares clinical record information for projects related to assessing the efficiency, effectiveness and quality of the delivery of managed care services. Prepares monthly performance reports
Assists in the planning and implementation of activities to improve delivery of services and quality of care including the development and coordination of in-service education programs for providers and other clinical staff
Provides training, interpretation and support for QI Clinical Reviewer staff
Responsible for auditing as well as validating internal audit results and/or corrective action plans

Senior Quality Manager Resume Examples & Samples

Driving creation of quality initiatives, process change initiatives, and other Change/Six Sigma initiatives to enable the network to meet and exceed business plans
Managing and developing direct reports
Developing and following network quality roadmap
Reviewing analysis of customer defect data with development of corresponding action plans to reduce defects
Developing and executing daily, weekly & monthly action plans that improve quality and delivery
Establishing and maintaining defect free handling procedures for all sites in the network
Planning for and identifying root causes of quality and delivery deviation through cause and effect analysis
Teaching and educating managers and associates on the importance of quality execution
Gaining consensus to push change forward while keeping variation between sites to a minimum
Traveling to sites to observe, investigate and create quality initiatives
5+ years Operations Management experience in manufacturing, production or distribution environment
Experience performing root cause analysis and driving quality improvements in an operations environment
Ability to handle changing priorities and use good judgment in stressful situations Six Sigma Black Belt preferred MBA preferred

Senior Quality Manager / Quality Manager Resume Examples & Samples

Serve as the Diagnostics expert on post market surveillance activities, ensuring sites are supported through the decision making activity, closure, and termination of issues
Assist in establishing robust and consistent evaluation methodology ensuring reporting of adverse events are consistenly applied across all Dx sites
Function as the Subject Matter Expert on post market surveillance matters
Drive continuous improvement and LEAN activities with the sites to improve efficiencies in post market activities
Function as the Dx champion for IT projects impacting the Quality function and/or systems
Oversee the Akron Quality team ensuring that all feedback mechanisms are captured and addressed in a timely maner
Provide quality support for the Dx service organization and partner with local sites for improvement activities
Manage regional quality managers in Mexico and APAC to suppor the Dx business
Oversee Waltham quality activities related to R&D as well as CCMS
Ownership responsibility for the Dx business level QMR, establishing and disseminating metrics applied across all sites
Extensive knowledge of ISO 13485, FDA CFR 820, and emerging standards and regulations
Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion; must be able to manage and lead without direct authority
Excellent judgment skills in order to provide strong guidance and counsel to the site and line staff
Time management skills for oneself and of others on a team, ability to drive projects to scheduled completion
Superior interpersonal, verbal and written communication skills
Exceptional organizational, negotiation, and problem solving skills
Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management

Senior Quality Manager Resume Examples & Samples

Member of site leadership team, contributes and participates on issues and interactions related to site quality
Responsible for working with Site Leadership Team to deliver on site goals and objectives
Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates best practices, and is consistent with the strategic plan
Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets
Educate and mentors employees on the site QMS and other quality/operational programs and processes
Provide the necessary leadership and strategic planning to develop, implement and maintain a quality assurance and quality control program to support the business mission and ongoing continuous improvement effort
Formulates and oversees maintenance of quality control objectives and coordination with production procedures to maximize product quality
Instill and maintain a quality culture
Provide input and direction to resolve quality related issues through proper inspections, root cause analysis and corrective actions plans
Ensure continuous improvement through the Practical Process Improvement (PPI)
Serves as key member of product teams, with focus on quality planning for new products/processes
Monitors quality performance for the Millersburg site, reports progress, and keeps division leadership informed of progress, issues, corrective action, and customer complaints
Provide direction to ensure compliance with all applicable customer requirements and government regulations involving product quality
Proven communication and customer management skills
Hands on knowledge of products and applications
Understands the BioProduction customer and required compliance regulations for our products and processes
Experience working and providing customer support, investigations, and relationship management
Must model the highest degree of moral and ethical behavior
Must maintain confidential information
Experience working successfully in a fast paced environment
Experience supporting change management efforts
Proactive and takes ownership for producing positive results
Contributes as a valued team member and colleague with leaders at all levels
Demonstrates personal awareness and desire for continual learning and personal development
Keeps commitments; exhibits candor and courage - is not afraid to establish a visible presence and point of view, to engage in spirited and constructive debate, to hold others accountable
Normally receives little instruction on day-to-day work, general instructions on new assignments
Must possess the presentation skills and professionalism to project a professional image, both internally and externally
Strong interpersonal, verbal and written communications skills are essential
Bachelor’s degree from an accredited higher learning institution
8+ years Quality experience
Experience working in a manufacturing and/or production environment
Good understanding of customers, products, and regulatory compliance

Senior Quality Manager Resume Examples & Samples

Providing Packaging Quality Assurance support in the manufacture of new and existing products
Ensuring the use of DanoneWave's innovation process methodology throughout the project
Overall Risk Management (eliminating risks through strong problem solving or by use of a specific control)
Coordinate package design activities with all other functional Quality managers involved in the Product Life Cycle (including Plant Quality Managers and the Sales & Supply Chain Quality Director)
Bachelor degree minimum, Master degree in Sciences or Engineering ideal ( Packaging, Mechanical, Chemical or related engineering science)
3- 5 years' experience in a packaging quality field (preferably in the food or beverage industry)
Experience in thermoforming, injection molding and extrusion blow molding
Experience with polyolefins (PE,PP,HDPE,PS), their properties and use as food containers
Knowledge in sachets, pouches and related flexible packaging
Experience in barriers properties of packaging materials
Experience in the use of statistical tools for problem solving
Prior experience within Manufacturing, R&D or Supply Chain is preferable, preferably within a FMCG (CPG) food manufacturing environment
Prior experience in packaging development
Knowledge of commercialization process, quality and food safety systems
Standing along/courage

Senior Quality Manager Resume Examples & Samples

Leads the quality program and associated initiatives for the organization
Serves as the liaison with customers/consumers on items of product quality or reliability
Manages the continuous review of quality programs including auditing and the formulation of new or revised policies and procedures to effect improvements, reduce costs, and enhance efficiencies
Assists technical and procurement teams in formulating new products and establishing standards for these products prior to initial production
Manages objectives of Quality Initiatives such as the analysis of returned/defective products; prepares reports of findings
Develops, formulates, and guides quality control programs that involve advanced inspection methods, devices, and control techniques
Provides leadership and personally conducts the use of Pure Fishing’s 8 step problem solving process
Conducts and/or oversees training as necessary to ensure organizational understanding of procedures, methods, uses of equipment and other quality control techniques
Performs standard management responsibilities including but not limited to planning, organizing, delegating, evaluating, budgeting, scheduling, etc
Develops and implements Lean training programs for the organization
Deliver training, coaching and sponsor learning projects on CI concepts, tools and techniques
Lead, facilitate and support Kaizens and other CI events and seeks corrective action from coworkers if results are not sustained
Develops and implements structure for Kaizen events
Leads and manages the value stream mapping process
Co-Leads the 3P New Product and Process Development Process
Assists and coaches in the development and implementation of MDI metrics, QCDSP Boards and the 5S Program
Develops a program to measure and evaluate the success of Lean programs
Establishes and controls budgets for appropriate cost centers
Ensures the consistent application of organization policies
Develops or approves recommendations to change systems, policies and procedures; ensures timely and accurate implementation
Minimum of eight (8) years of progressive experience and training in quality assurance and control techniques within the Consumer Packaged Goods (CPG) industry required
Minimum of four (4) years of experience in test laboratory procedures required
Strong background in high volume manufacturing of consumer products required
Strong computational and analytical ability as it relates to calculations and analysis of quality assessment in a manufacturing environment required
Experience with International Standards Organization (ISO) standards required
Experience implementing quality management systems and procedures required
Minimum of intermediate level proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, and Outlook) required
Must be eligible to work in the United States for any employer
Prior supervisory and managerial experience preferred
Special training in Industrial Management and / or applied engineering services preferred
Advanced proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, and Outlook) preferred
Experience functioning within a strong matrix environment of a global enterprise highly preferred

Senior Quality Manager Resume Examples & Samples

Four year college or equivalent
Five years job related experience
Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching
Demonstrated understanding of the principles of Human/Animal research protection standards
Strong knowledge of grants and contracts function
In-depth understanding of operational requirements pertaining to management and implementation of protocol process
Strong communication and presentation skills (verbal and written)
Direct IRB or IACUC experience, preferably with an AAHRPP or AAALAC accredited institution. Advanced knowledge of human subjects/animal protection regulations and best practices, as evidenced by certification (e.g., ability to obtain or retain IRB or IACUC professional )

Senior Quality Manager Resume Examples & Samples

Leads a program or multiple projects within a domain in a fast-paced, dynamic environment, which may include directing global sourcing resources as well as virtual teams. Projects are of a scope and complexity that usually impact multiple Lines of Business as well as functional areas, may have executive sponsorship and in some cases a steering or advisory committee and may span several years
Defines and manages testing in these areas: scope, scope changes, objectives, requirements, deliverables, and value proposition that support the diverse business goals and interests of multiple stakeholders
Drafts and submits testing budget proposals and recommends subsequent budget changes where necessary; conducts cost forecasting and actual tracking as well as variance reporting
Reviewing all the test deliverables, ownership of the quality assurance process for testing, responsibility for the integration of testing into release management and change management within the ITIL/ ITSM process framework,
Communicating accurate status/health information to delivery Project managers and Delivery managers including escalation along with risks & mitigations in summary level
Ensuring quality milestones/reviews are done on timely manner and making sure the that Key performance indicators and service level agreements are being met and enforced
Strong experience in using HP Quality Center tool. Quality Center Admin activity as an added advantage
Excellent Technical, Communication, Interpersonal and problem solving skills
Thinks, plans and executes on multiple levels
Can clearly articulate vision for future state; provide big-picture view/ enterprise view; decisive and directive when necessary
Fosters and encourages frequent, open and honest feedback; learns from setbacks and mistakes to drive improvements; independently seeks out learning opportunities

Senior Quality Manager Resume Examples & Samples

Establish operating policies and procedures defining requirements for responsible areas
Establish and manage departments performance metrics and goals
Maintain team performance to ensure objectives for key metrics are met, including timely regulatory filings, complaint closure, and patient data entry
Provide leadership and develop and implement methods to improve teams’ effectiveness and performance versus established quantitative measures
Frequently interact with senior-level management to inform, influence and achieve objectives
Ensure completeness, thoroughness and compliance of all HVT complaint files
Provide routine and ad hoc complaints reporting for management and external agencies
Provide liaison between Quality, Manufacturing and R&D to ensure timely and value-adding analysis of customer complaints
Support internal audits and external audits from various regulatory agencies
Ensure compliance with regulations including 21CFR820 and 803, ISO13485, Canadian MDR, JPAL, and MDD 93/42/EEC, ISO14971
Manage personnel ensuring growth and professional development
A Bachelor’s degree in a scientific or related discipline is required; advanced degree is desirable
A minimum of ten years’ experience in the medical device or similar regulated industry, with a demonstrated track record in management
Complaint handling experience in the medical device industry required
Experience working in a clinical setting is desirable
People management including roles definition, team optimization, and conflict resolution
Strong management and leadership skills to ensure growth, and development of personnel
Ability to resolve issues and answer questions independently, with judgment to escalate issues when appropriate
Strong communication skills, including written, verbal, and presentation skills
Ability to identify appropriate means, style and depth of communication depending on audience
Strong understanding of US FDA and international regulatory standards for medical devices
Highly developed time management skills, including an ability to manage multiple and frequently changing projects and priorities

Senior Quality Manager Resume Examples & Samples

Drug screen / background check
U.S Citizenship (NO sponsorship)
Participates in the interview and selection process (including hiring recommendations), and makes staffing assignments in accordance with schedule requirements. Conducts performance evaluations and makes appropriate recommendations for required actions, including recommendations for advancement, changes in status, or disciplinary action. Manages the salary administration process, including preparing the annual salary plan and recommending salary actions for merit increases and/or promotions
Provides Client Quality Systems leadership using the ISO 9001 Standard as the basis for process development and optimization, procedure development, data collection and reporting, and Quality Systems training. Directs and coordinates efforts to initiate (and maintain) Regional/ Project ISO 9001 QMS certification
Implements the defined Client? Corrective Action/ Preventive Action and Non-conformance
Tracking program development including defining requirements and future administration and support of a unified, system to include tracking of NCRs, CARs, Audit Findings, etc
Collaborates with the Vice President, OSS Quality or Vice President, PGS Quality and Compliance, in facilitating Quality Leadership programs, achieving present Quality objectives, setting future Quality objectives and providing input and coordinating output from the Quality Management Reviews
Provides leadership, guidance and training to Quality personnel; monitors performance, and identifies skills, training, and capabilities needed for Quality activities. Develops and provides consistent quality training programs to key Resource Center personnel including direct reports. Provides Quality support in the Client Guidance Document Development Program initiative. Supports staffing requirements in the Regional Units, and assisting in the training needs of related Offices, Projects and Facilities
Provides continued support and improvement of the Client? Quality Management System
Directs preparation, issue and maintain Regional and/or project Quality program manual(s) and
Procedures in compliance with Client and customer quality requirements, and ensure that these are implemented effectively
Ensures that Client and customer’s quality requirements are met for products and services provided, by verifying compliance with quality standards and quality program requirements. Acts as a liaison with customers, contractors and/or internal departments on quality related matters. Interfaces with other Regional Quality Managers as member of Corporate Quality Working Group to maintain the PACE Quality Guide and advance the overall performance of quality at Client
Identifies and reports to executive management, quality issues or trends based on data from a variety of sources. Provides input to management on organization performance metrics, and process or procedural system improvements

Senior Quality Manager Resume Examples & Samples

Lead and develop team members through training, communication, and accountability
Demonstrate knowledge of product and processes, and their impact on overall quality
Primary technical liaison with customers, vendors, and regulatory agencies
Support co-manufacturing sites for additional sites in the US
Bachelor’s degree from an accredited institution in an applicable field of study such as Food Science, Chemistry, Biochemistry, Microbiology, or similar Science/Engineering
Demonstrated success with relevant GFSI standards including SQF, BRC, IFS, or FS 22000
Proven knowledge and understanding of Food Safety regulations, FSMA, and industry and market trends
ASQ Quality Engineer certification (CQE) or equivalent. Candidates may pursue this certification concurrently, but must be able to demonstrate competency with statistical analysis
Six sigma and/or lean manufacturing experience is desirable. Ability to drive continuous improvement and change management initiatives
Proven success in communicating with customers and responding effectively to quality concerns
Must have strong critical thinking ability along with analytical and problem solving skills
Achievement in assessing, developing and retaining top talent
Proven ability to lead with the following key competencies: Technical Expertise, Strategic Thinking & Influence, Process Optimization & Product Knowledge, and Leading & Managing Change

Customer Service Senior Quality Manager Resume Examples & Samples

Ensure all internal,and external non-conformances are tracked with measurable progress of corrective actions in a timely fashion
Produce, and report, Quality metrics and Key Process Indicators (KPI’s) as required by the QMS
Manage internal audit programs to establish consistent adherence to all QMS and Regulatory requirements
Administration of Corrective and Preventative Action (CAPA) system
Lead and develop a quality team with skills and abilities to become a true service organization to support all customer service teams in training and technical troubleshooting to achieve company goals and objectives
Develop and provide training to CS employees and other stakeholders as required
May work on special projects/assignments upon request
Be able to lead / sponsor / manage all aspects of Continuous Improvement programs to meet defined objectives and goals
Job Requirements
Bachelor’s or Master’s degree, or equivalent
Fluent in English. Additional languages is a plus
More than 5 years experience in Customer Service Quality departments minimum. Desired more than 10 years experience

Senior Quality Manager Resume Examples & Samples

Coach, mentor and lead quality team
Design, implement, maintain, and evaluate quality systems for aquatics, liquid filling and packaging operations
General problem solving for aquatics and liquid packaging including root cause analysis and corrective action implementation
Provides advice and counsel to Purchasing in connection with the selection of vendors and purchase of materials; requests the R&D department for required or changed material specifications; arrange where necessary for inspection of vendor’s plants to insure conformity to specifications and adherence to stated manufacturing process
Manage and maintain network SPC data collection system (Gainseeker SPC)
Analyzes, interprets, and prepares reports concerning Quality, effectiveness, costs and cost reductions, laboratory problems, status of equipment and initiates appropriate action
Develop, analyze, and present Key Performance Indicators as they relate to plant quality
Take ownership of the quality system and continued improvements to the plan
Resolve quality issues related to product components
Responsible for the selection and training of employees; planning, assigning, ad directing work; appraising employee performance; rewarding and disciplining employees; addressing complaints and resolving problems and disputes
Comply with all Company policies and procedures
Bachelor’s degree in Engineering or related science
Seven to ten years of experience in Quality Management of consumer products (or equivalent combination of education and/or experience)
Experience managing exempt and non-exempt employees
Excellent Leadership Skills
Ability to initiate resolutions for major quality issues
Solid background in quality engineering; experience in experimental design is preferred

Senior Quality Manager Resume Examples & Samples

Minimum of 10 years experience in Quality ideally in the Medical Device industry
Supervisory and/or Managerial experience within a Quality department
Extensive exp./knowledge in Quality Management Systems (ideally Agile)
Very Hands-on role (80% hands-on & 20% managerial)
Exp. working in a ISO 9000 and/or 1345 environment
Microbiology background
Consumable manufacturing background
Cleanroom background
Lean/Six sigma experience is a plus
MRP/ERP experience
Main duty will be oversight of the Quality Management System
Will have a few direct reports
Very hands-on role

Senior Quality Manager Resume Examples & Samples

Lead, manage and develop team per WWT Integrated Management and Leadership Concepts
Collaborate with onsite Quality teams to ensure standardization across QMS and new/changed requirements are being met
Ensure overall effectiveness of the QMS across the organization
Oversee the implementation of new and revised QMS requirements and standards
Ensure Quality tools and concepts are being utilized properly within the organization, as needed (Risk Analysis, Root Cause Analysis, Change Management, Continuous Improvement)
Collaborate with onsite quality teams to ensure KPIs are being monitored, measured and analyzed and corrective actions are assigned, as needed
Minimum 10 years general business experience; quality, supply chain or logistics preferred
Minimum 5 years of experience in the support with Quality Management Systems; ISO 9001 and/or TL 9000 certification preferred
Bachelor’s Degree or Associate Degree with 5 years of experience supporting a mature QMS or equivalent experience
Experience in the management and leadership of a team required
Minimum 5-7 years’ experience in the management and leadership of a team required
Proven track record in Closed-Loop Corrective Action resulting in sustainable process improvements
Experience in leading others, establishing priorities and accomplishing objectives with minimal supervision
Excellent oral and written communication and interpersonal skills
Independent, professional, and self-motivated
Potential to travel 10 percent

Senior Quality Manager Resume Examples & Samples

Support co-manufacturing sites for additional sites in the US –Melrose Park IL Evansville IN, Sturtevant WI, Calhoun GA, Brampton Ontario
Travel 50-75%
Bachelor’s degree from an accredited institution in an applicable field of study such as Food Science, Chemistry, Biochemistry, Microbiology, or similar Science/Engineering and 7+ years of relevant progressive quality and leadership experience
Experience in coatings, batters and seasonings is preferred. USDA experience is a plus

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Senior Quality Manager Resume Examples & Samples

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