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Quality Assurance Manager - Medical Device

  • Job type: Permanent
  • Location: Windsor
  • Salary: $90000 - $130000 per annum
  • Job reference: MERZ011118441
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 11/01/2018
  • Windsor, CT
  • $90,000 - $130,000 + Bonus + Benefits + Excellent Career Growth
The Quality Assurance Manager will provide leadership to include in-process quality assurance, quality inspection, document control, process monitoring, acceptance testing, validations, and final release activities. This role will overlook Quality Engineering, Quality Assurance, and Document Control to ensure compliance to all standards and regulations, in addition to customer requirements. The Quality Assurance Manager will improve and maintain the effectiveness of the QMS throughout an on-going basis. 

The Quality Assurance Manager will be have the following responsibilities:
  • Overlook all Quality activities
  • Implement and maintain ISO 13485, ISO 9001, FDA, GMP, as well as all Medical Device standards and regulations in QA, R&D and Manufacturing areas
  • Manage change control for quality system effectiveness
  • Develop and lead all process, equipment and product validations
  • Act as the main contact within Quality

The Quality Assurance Manager will have the following skills & experiences:
  • 3+ Years experience within a Quality Assurance managerial position in Medical Device Industry
  • BS Degree in Sciences (Biomedical Engineering, Chemical Engineering, Mechanical Engineering, or similar)
  • Strong working knowledge in relation to ISO 13485, ISO 9001, 21 CFR 820, 21 CFR 210/211 and FDA requirements
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