Quality Manager/Director

Found in: Talent US C2 - 2 weeks ago

Holland, United States MB&A Full time
Job Description

Summary:

We are seeking a dedicated Quality Manager/Director to join a team for a leading contract manufacturer specializing in orthopedic and trauma implants in Holland, Michigan. If you are passionate about shaping and elevating quality standards in a dynamic environment, we invite you to be a key player in our ambitious quality management team.

Responsibilities:

As a Quality Manager/Director, you will play a pivotal role in the development and implementation of quality management systems, ensuring compliance with EN ISO 13485, 21 CFR Part 820, and ISO 14971 for risk management. Your responsibilities will include:


  • Continuous improvement and application of quality management systems, collaborating with various departments.
  • Oversight of the CAPA system for internal and external complaints.
  • Planning, execution, and follow-up of internal and external audits.
  • Designing process and quality improvements, and coordinating change management.
  • Creation, implementation, and monitoring of corrective measures, aligning with market and customer requirements.
  • Coordination and leadership of the Quality Management (QM) team, fostering motivation, and professional development.
  • Serving as a sparring partner and supporting team members in problem-solving.

Management Responsibilities:

As the head of the Quality Management department, you will:

  • Professionally lead the QM team.
  • Motivate and develop team members, fostering a culture of top performance through fairness, honesty, and trust.
  • Proactively take responsibility for activities, delegate effectively, and provide support during challenges.
  • Communicate clearly and precisely, guiding and motivating employees, resolving conflicts competently, and delivering constructive feedback.

Quality Management Responsibilities:

You will be responsible for:

  • Developing, optimizing, and systematically applying management systems (EN ISO 13485, 21 CFR Part 820, EN ISO 14971) and ensuring regulatory compliance.
  • Initiating and implementing concepts and procedures for process and quality improvement, coordinating change management.
  • Planning and implementing validation and qualification of production facilities.
  • Supervising the introduction of new processes and their documentation in the quality management system.
  • Designing CAPA systems for processing internal and external complaints, and initiating corrective and preventive measures.
  • Coordinating customer complaints, supporting error analyses, process optimizations, and initiating corrective measures.
  • Planning, implementing, and meticulously following up on internal and external audits.
  • Preparing and reviewing quality agreements and supplier declarations with suppliers and customers.
  • Creating, initiating, processing, and monitoring corrective measures, and organizing the quality area according to market and customer requirements.


Requirements

Qualifications:

To excel in the role of Quality Manager/Director, we are seeking candidates with the following qualifications:


Education:

  • Bachelor's degree in a relevant field; advanced degree preferred.
  • A technical degree or equivalent training with practical experience, ideally related to ISO 13485.

Experience:

  • Extensive experience in quality management, including leadership roles.
  • Experience in machining processes and a strong background in Quality Management.

Skills:

  • Strong understanding and application of relevant standards and regulations (EN ISO 13485, 21 CFR Part 820, EN ISO 14971).
  • Methodological skills for root cause analysis and problem-solving (e.g., 5-Why, Ishikawa, brainstorming).
  • Proven ability to lead and motivate teams, with excellent communication and conflict resolution skills.
  • Experience in developing and optimizing management systems and implementing change management processes.
  • Solid knowledge of validation and qualification processes for production facilities.
  • Familiarity with CAPA systems and handling customer complaints.
  • Excellent communication skills and high-quality standards.
  • Ability to communicate effectively at a high technical level.

Attributes:

  • Team spirit while maintaining a focus on individual results.
  • Analytical thinking and fact orientation.
  • Excellent organizational skills and attention to detail.
  • Strong analytical and problem-solving capabilities.


Requirements
Knowledge of regulatory requirements, particularly in qualification, validation, and manufacturing guidelines for medical devices (DIN ISO 13485, 21 CFR Part 820, GMP Annex 15, DIN EN ISO 14971). Desirable knowledge in the validation of computerized systems and software (21 CFR Part 11, GMP Annex 11, GAMP 5).

  • Quality Manager/Director

    2 weeks ago

    Holland, United States MB&A Full time

    Job Description Job Description Summary: We are seeking a dedicated Quality Manager/Director to join a team for a leading contract manufacturer specializing in orthopedic and trauma implants in Holland, Michigan. If you are passionate about shaping and elevating quality standards in a dynamic environment, we invite you to be a key player in our ambitious...

  • Quality Manager/Director

    2 weeks ago

    Holland, United States MB&A Full time

    Job DescriptionJob DescriptionSummary: We are seeking a dedicated Quality Manager/Director to join a team for a leading contract manufacturer specializing in orthopedic and trauma implants in Holland, Michigan. If you are passionate about shaping and elevating quality standards in a dynamic environment, we invite you to be a key player in our ambitious...

  • Manager, Quality

    2 weeks ago

    Holland, United States LG Energy Solution Michigan, Inc. Full time

    Job DescriptionJob DescriptionTitle: Manager, Quality Assurance (Pack)Reports to: Sr. Manager, Quality Assurance Location: Holland, MILG Energy Solution Michigan Inc. (LGESMI) develops and manufactures large lithium ion polymer batteries and packs for electric vehicle (EV) and energy storage applications. Come join the leader in advanced EV batteries!...

  • Supplier Quality Manager

    Found in: Appcast Linkedin GBL C2 - 2 days ago

    Holland, United States Hudsonville Creamery and Ice Cream Company Full time

    ­­Position Summary The Supplier Quality Manager is responsible for the food safety and quality (FSQ) of materials used in and for the manufacture of Hudsonville Ice Cream (HIC) products. This role, with the support of quality and purchasing management, is responsible for executing the Supplier Quality Strategy and driving its continuous improvement and...

  • Supplier Quality Manager

    Found in: Appcast US C2 - 2 days ago

    Holland, United States Hudsonville Creamery and Ice Cream Company Full time

    ­­Position Summary The Supplier Quality Manager is responsible for the food safety and quality (FSQ) of materials used in and for the manufacture of Hudsonville Ice Cream (HIC) products. This role, with the support of quality and purchasing management, is responsible for executing the Supplier Quality Strategy and driving its continuous improvement and...

  • Supplier Quality Manager

    2 days ago

    Holland, United States Hudsonville Creamery and Ice Cream Company Full time

    ­­Position Summary The Supplier Quality Manager is responsible for the food safety and quality (FSQ) of materials used in and for the manufacture of Hudsonville Ice Cream (HIC) products. This role, with the support of quality and purchasing management, is responsible for executing the Supplier Quality Strategy and driving its continuous improvement and...

  • Plant Quality Manager

    2 weeks ago

    Holland, United States Clarion Technologies Full time

    Job DescriptionJob DescriptionManagement position with emphasis placed upon the planning, coordination, implementation, and follow-up of tasks that support all efforts of the Quality Department.Develop and analyze various data and product specifications to determine present standards.Define and communicate system and product quality performance...

  • Quality Engineering Manager

    Found in: beBee S US - 1 week ago

    Holland, United States Magna International Inc. Full time

    #jobreq_print_container div { line-height: 14px; } #jobreq_print_container div span { font-size: 12px; } About us We see a future where everyone can live and move without limitations. That’s why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our communities, the planet and, above all,...

  • Quality Manager

    3 weeks ago

    Holland, United States HR Solutions Group Full time

    Job DescriptionJob DescriptionEBW Electronics (EBWE) is currently seeking to fill a key role, Quality Manager to provide leadership, growth, and continuous improvement in the quality of materials, internal processes, and finished products. As our Quality Manager, you will be an active member of our Operations Management Team and report to our Vice President...

  • Production Manager/Director

    2 weeks ago

    Holland, United States MB&A Full time

    Job DescriptionJob DescriptionObjective of the Position:A Production Manager oversees manufacturing processes, focusing on optimizing efficiency, minimizing material waste, and ensuring production meets specified quality requirements. The role involves managing all primary production activities, capital and process development projects, and providing...

  • Quality Engineer

    Found in: Appcast US C2 - 3 days ago

    Holland, United States Adient Full time

    SummaryThe Quality Engineer coordinates, administers, and performs the quality function of an engineering and technical nature to ensure product quality and reliability at minimum quality costs. Assumes a responsible leadership role in the successful launch of new programs. Serves as the main quality point of contact for intracompany and external customers....

  • Quality Engineer

    Found in: Appcast Linkedin GBL C2 - 3 days ago

    Holland, United States Adient Full time

    SummaryThe Quality Engineer coordinates, administers, and performs the quality function of an engineering and technical nature to ensure product quality and reliability at minimum quality costs. Assumes a responsible leadership role in the successful launch of new programs. Serves as the main quality point of contact for intracompany and external customers....

  • Manager, Planning

    2 weeks ago

    Holland, United States LG Energy Solution Michigan, Inc. Full time

    Job DescriptionJob DescriptionTitle: Manager, Quality PlanningReports to: Director of QualityLocation: HollandLG Energy Solution Michigan Inc. (LGESMI) develops and manufactures large lithium ion polymer batteries and packs for electric vehicle (EV) and energy storage applications. Come join the leader in advanced EV batteries! www.lgenergymi.comSummary:As a...

  • Director of The Lakeshore Housing Alliance

    2 days ago

    Holland, United States Good Samaritan Ministries Full time

    **Position Summary** The Director of the Lakeshore Housing Alliance is responsible for the Continuum of Care (CoC) for Ottawa County which is a planning and coordinating body promoting the ending of homelessness. The CoC Coordinator facilitates the community initiative and prepares state and federal grant proposals. This position also provides oversight and...

  • Engineer I, Quality

    2 weeks ago

    Holland, United States LG Energy Solution Michigan, Inc. Full time

    Job DescriptionJob DescriptionTitle: Engineer I, Quality (Customer Service)Reports to: Manager, CS QualityLocation: Holland, MI LG Energy Solution Michigan Inc. (LGESMI) develops and manufactures large lithium ion polymer batteries and modules for electric vehicle (EV) and energy storage applications. Come join the leader in advanced EV batteries!...

  • Engineer I, Quality

    3 days ago

    Holland, United States LG Energy Solution Michigan, Inc. Full time

    Job DescriptionJob DescriptionTitle: Engineer I, Quality (Customer Service)Reports to: Manager, CS QualityLocation: Holland, MI LG Energy Solution Michigan Inc. (LGESMI) develops and manufactures large lithium ion polymer batteries and modules for electric vehicle (EV) and energy storage applications. Come join the leader in advanced EV batteries!...

  • Director of Manufacturing

    2 weeks ago

    Holland, United States CareerBuilder Full time

    Location : 1401 S. Washington, Holland, MI 49423 Who We Are: Challenge is a leading employee-owned tier 1 supplier of complex metal assemblies for the global automotive industry. Challenge fosters a culture of collaboration, diversity, and innovation. We believe the best ideas come from individual unique perspectives. These ideas combined with the teamwork...

  • Engineer I, Quality

    1 week ago

    Holland, United States LG Energy Solution Full time

    Title: Engineer I, SQA Reports to: Manager SQA Location: Holland, MI LG Energy Solution Michigan Inc. (LGESMI) develops and manufactures large lithium-ion polymer batteries and packs for electric vehicle (EV) and energy storage applications. Come join the leader in advanced EV batteries! www.lgenergymi.com Summary: This Job is responsible for ensuring a...

  • Director of Nursing DON RN

    2 weeks ago

    South Holland, United States CareerBuilder Full time

    Elevate Care South Holland - Exciting Career Opportunity: Director of Nursing Are you a dynamic and experienced nursing leader ready to significantly impact the SNF healthcare space? We seek a visionary Director of Nursing to join our dedicated team and lead the way in delivering exceptional patient care. Elevate Care is a reputable and patient-centered LTC...

  • Collections Manager Kruizenga Art Museum, Hope College, MI

    2 weeks ago

    Holland, United States CareerBuilder Full time

    Collections Manager Kruizenga Art Museum, Hope College, MI The Hope College Kruizenga Art Museum (KAM) seeks a Collections Manager to oversee its collection of more than 10,000 artworks representing a broad range of media, cultures, and historical periods. The museum building occupies approximately 11,000 square feet, with approximately 4,500 square feet of...