Senior Quality Assurance Engineer

Job Title:

Senior Quality Assurance Engineer

Location:

Redmond, WA (4 Days On-Site / 1 Day Remote) Job Type: Full-time, Contract (18 Months) About the Role A global leader in medical device technology and healthcare equipment is seeking a Senior Quality Assurance Engineer to oversee process control, quality performance, and defect reduction. This individual contributor role focuses on managing non-conformances, driving supplier quality initiatives, and supporting manufacturing process validations.

Key Responsibilities Non-Conformance & CAPA Management:
Lead root cause investigations for internal and supplier-driven quality issues; own, process, and close NC and CAPA records using Track Wise. Supplier Quality Ownership:
Collaborate with suppliers on non-conformances, issue SCARs, execute Supplier Initiated Change Requests (SICRs), and manage PPAP activities for supplier changes. Process Improvement & Validation:
Support manufacturing and distribution process improvements, equipment/process validation, and Measurement System Analysis (MSA). Complaints & Field Actions:
Assist in manufacturing-related complaint investigations, MRB product dispositions, and product field actions. Metrics & Compliance:
Maintain quality KPIs, analyze defect trends, and ensure continuous adherence to regulated quality system procedures. Requirements

Education:

Bachelor's Degree in Engineering or a related technical field.

Experience:

2+ years of Quality Engineering experience within medical devices, biotechnology, or a heavily regulated manufacturing environment. Technical

Skills:

Hands-on experience with quality systems (e.g., Track Wise), CAPA execution, non-conformances (NC), PPAP, and process validations.

Schedule:

On-site in Redmond, WA 4 days per week (1 day remote).