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Quality Assurance Specialist

1 month ago

Redmond, Washington, United States GForce Life Sciences Full time

At GForce Life Sciences, we are seeking a Quality Assurance Specialist to join our team. The successful candidate will work closely with Operations and business functions to ensure quality performance of products and processes.

Key Responsibilities:

  • Collaborate with internal cross-functional and supplier teams to address top quality issues.
  • Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
  • Support execution and analysis of manufacturing-related complaint investigations and product field actions.
  • Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
  • Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
  • Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval.
  • Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

Requirements:

  • Bachelor's Degree in Science/Technical Field
  • Minimum 3 years of related experience
  • CAPA experience
  • Experience with Trackwise/ERP Systems
  • Previous medical device experience, familiarity with ISO 13485, GDP, as well as GMP