Quality Assurance Manager

4 days ago

Seattle, Washington, United States BioTalent Full time

The Quality Manager will provide direct leadership for the team, ensuring the effectiveness of the Seattle Operations site Quality Management System. This role will manage the Change Management Board, Validation Review Boards, training program, Management Review, and site quality initiatives. The Quality Manager will review data for trends, manage corrections and corrective action, and support Global Supply Chain and business partners as requested. This is an on-site role in our Woodinville, WA site.

Key Responsibilities:

  • Lead the Quality System Specialist team, developing development plans and supporting growth and success.
  • Improve the overall efficiency of the Quality Management System by launching and supporting global initiatives to drive standardization and alignment.
  • Support the release of high-quality product by conducting thorough quality review of documentation to ensure compliance.
  • Maintain the integrity of the Quality Management System by following up on action items and driving completion.
  • Support internal and external audits by representing quality documentation and responding to findings in a timely manner.

Background Requirements:

  • Bachelor's degree or equivalent in a related field required.
  • 5+ years' relevant quality systems experience with supervisory experience, or equivalent combination of education and experience.
  • Ability to work well in fast-paced and cross-functional teams.
  • Working knowledge of the device/drug/biotech manufacturing process.
  • Experience with risk management regulations and application.
  • Understanding of working in a regulated environment 21 CFR 820 and ISO 13485 and 14971 standards as they apply to manufactured products.

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