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