Quality Assurance Manager
2 days ago
Job Summary: We are seeking a highly skilled Quality Manager to oversee the development and maintenance of quality systems in our Plymouth, MN OEM facility.
Key Responsibilities:
- Supervise and manage the development and maintenance of all plant quality systems, including supplier development, calibration, internal auditing, CAPA, quality engineering, and production support efforts.
- Manage OEM complaint handling and establish compliance training programs.
- Ensure that necessary regulatory corporate compliance systems are in place and adhered to.
- Represent quality for new product development and provide statistical support as needed throughout the plant.
- Serve as the Management Representative for the Plymouth MN OEM facility.
Requirements:
- Bachelor's Degree in Engineering, Physical Science, or similar field.
- Minimum 7 years of medical device industry experience, with contract manufacturing experience preferred.
- Minimum 5 years of related quality experience in a manufacturing environment.
- Minimum 3 years of supervisory or management experience.
- ASQ CQA or CQE certification highly preferred.
Specialized Skills:
- Strong leadership and management skills.
- Demonstrated experience in mentoring and coaching others.
- Contract Manufacturing, Regulatory, cGMP, QSR, knowledge base.
- Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison).
- Strong computer skills (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.).
- Strong negotiation and problem-solving skills.
- Ability to operate and communicate effectively with multiple teams.
- Supplier auditing knowledge and ability (i.e. ASQ-CQA, internal/external courses, seminars).
- Able to understand blueprints, tolerance analysis, and related knowledge.
- Strong reasoning/analytical skills, including the ability to support and prioritize projects and adapt to shifting priorities.
- Work with minimal supervision.
- Able to successfully resolve problems and conflicts.
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