Senior Quality Assurance Engineer

Supplier Quality Ownership: Collaborate with suppliers on non-conformances, issue SCARs, execute Supplier Initiated Change Requests (SICRs), and manage PPAP activities for supplier changes. Non-Conformance & CAPA Management: Lead root cause investigations for internal and supplier-driven quality issues; own, process, and close NC and CAPA records using TrackWise.

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 TrackWise.

• 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., TrackWise), CAPA execution, non-conformances (NC), PPAP, and process validations.

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