Summary:

We are seeking a dedicated Quality Manager 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:

• 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:

• 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.

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.

Job Type: Full-time

Salary: $120,000.00 - $135,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Will you now or later require Sponsorship to work in United States?
• Do you have experience with-in Medical Device Manufacturing Industry?
• Do you have experience in machining processes?

Education:

• Bachelor's (Required)

Experience:

• Quality management: 7 years (Required)
• Medical Device: 5 years (Required)
• APQP: 5 years (Preferred)
• CAPA: 5 years (Required)
• ISO 13485: 5 years (Required)

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Holland, MI 49423 (Required)

Ability to Relocate:

• Holland, MI 49423: Relocate before starting work (Required)

Work Location: In person