Quality Assurance Manager

2 weeks ago


Somersworth, New Hampshire, United States Purcell International Group Full time
Quality Assurance Supervisor

Purcell International Group is seeking a highly skilled Quality Assurance Supervisor to join our team. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.

Key Responsibilities:
  • Supervise and support quality assurance and quality manufacturing functions to ensure compliance with regulatory requirements and company standards.
  • Develop and implement quality metrics and records to track and analyze performance.
  • Provide supervision and guidance to quality inspectors to ensure effective coverage and support of manufacturing operations.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Ensure compliance with ISO 13485, ISO 9001, and FDA 21 CFR Part 21 Quality System Regulation.
Requirements:
  • Bachelor's degree in a technical field.
  • 2+ years of experience in medical device quality assurance with knowledge of ISO 13485 and FDA 21 CFR Part 21.
  • Knowledge of 21 CFR Part 820 and ISO 13485 quality systems.
  • Ability to supervise and organize QA personnel to provide support and coverage in support of production activities and schedules.

Purcell International Group offers a competitive salary and exceptional benefits package. If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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