Director of Quality Assurance

Responsibilities and Duties:

  • Serve as the Quality System Management representative
  • Primary liaison between organization and regulatory agencies
  • Enforce compliance with regulatory requirements through internal and external auditing and maintain evidentiary records by supporting procedure development, implementation and reviews appropriate to the organization
  • Interpret regulations and apply knowledge of quality system standards such as ISO13485, CFR21 Part 820, SOR98-282 Health Canada
  • Facilitate customer complaint reviews to ensure global regulatory compliance (FDA, MDD, CMDR, etc.)
  • Create, review and edit technical documents for regulatory submissions to ensure clarity, accuracy, completeness, logical flow and structure.
  • Prepare and manage submission of documents to global regulatory authorities.
  • Oversee and manage all departments and activities within the Quality Assurance Department
  • Provide resources and budgets necessary for performance of all QA functions
  • Ensure that QA personnel trained to standard necessary for quality system administration
  • Ensure that audits of the quality system are performed in an efficient, timely and complete manner
  • Implement cost reduction measures within Quality Department
  • Maintain knowledge of quality and regulatory regulations including proposed and final rules.
  • Approve quality systems developed and used to monitor product quality

Qualifications:

  • Minimum of 7 years’ experience in medical device
  • Minimum of 5 years’ experience in industrial manufacturing environment
  • 4 year degree in a scientific or Engineering discipline required,
  • Experience in dealing with the FDA directly (front room)
  • Audit certifications in ISO 9001 and 13485 (at least one)
  • Knowledgeable of FDA Quality System Regulations 21 CFR Part 820
  • Leadership experience required, must currently manage at least 3 direct reports
  • Previous responsibility for Customer Complaint and MDR process preferred
  • Previous CAPA Management
  • Master’s degree or MBA preferred
  • ASQ CQA
  • RAPS RAC
  • Experience with CNC machining
  • Personal characteristics necessary for success:
  • Tenacity, direct but tactful nature, decisiveness, ethical, flexibility, ability to gain consensus, team builder, passionate, persistent, patient, and assertive.