Quality Assurance Manager

24 hours ago


Rochester, New York, United States Michael Page Full time
Job Summary

We are seeking a highly experienced Quality Control Manager to lead our Medical Device Manufacturing team. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and team leadership.

Key Responsibilities
  • Develop and implement quality control policies and procedures to ensure compliance with regulatory requirements.
  • Plan and oversee quality control activities across all stages of the product lifecycle.
  • Lead and mentor a team of quality control inspectors, technicians, and engineers.
  • Ensure proper training and development of quality control 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 compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.
  • Investigate and resolve quality issues, including non-conformances, product failures, and customer complaints.
  • Implement corrective and preventive actions to address root causes of quality issues.
  • Collaborate with cross-functional teams to implement process improvements and enhance product quality.
Requirements
  • 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.
What We Offer
  • Base Salary of $100,000-$125,000 depending on experience.
  • Bonus.
  • 401K Match.
  • Health, Dental, Vision.
  • PTO.


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