Senior Quality Assurance Engineer at Comrise Senior Quality Assurance Engineer at Comrise in Bellevue, Washington Posted in 5 days ago.

Type:

full-time

Location:

Redmond, WA (4 Days On-Site / 1 Day Remote)

Duration:

18-Month W2 Contract 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.