Quality Assurance Engineer
12-month+ contract
Onsite in Redmond, WA
Responsibilities:
• Work closely with Operations and the business functions to ensure quality performance of product and processes.
o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
o 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.
o Support execution and analysis of manufacturing related complaint investigations and product field actions.
o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval
o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
Qualifications:
- 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