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Quality Control Manager
1 month ago
The Quality Control Manager - Medical Device Manufacturing will be responsible for developing, implementing, and managing quality control policies, procedures, and protocols to ensure compliance with regulatory requirements. This includes planning and overseeing QC activities across all stages of the product lifecycle, leading and mentoring a team of QC inspectors, technicians, and engineers, and ensuring appropriate training and continuous development of QC personnel.
Key Responsibilities- Develop and implement quality control policies, procedures, and protocols to ensure compliance with regulatory requirements.
- Plan and oversee QC activities across all stages of the product lifecycle.
- Lead and mentor a team of QC inspectors, technicians, and engineers.
- Ensure appropriate training and continuous development of QC personnel.
- Oversee routine inspections and audits of raw materials, in-process materials, and finished products.
- Manage the implementation of quality testing for new and existing products.
- Ensure proper calibration and maintenance of QC equipment and tools.
- Maintain accurate and up-to-date documentation of QC activities.
- Lead internal audits and support external regulatory inspections.
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.
- Bachelor of Science in Mechanical Engineering, Industrial Engineering, or a related field.
- Managerial experience required.
- 5+ years of experience within a Medical Device Manufacturing Company or a related industry.
- Document Control experience required.
- ISO 13485 knowledge.
- Base Salary of $100,000-$125,000 depending on experience.
- Bonus.
- 401K Match.
- Health, Dental, Vision.
- PTO.
