Senior Quality Assurance Engineer
Listed on 2026-07-09
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Title:
Senior Quality Assurance Engineer
Location:
Redmond, WA, USA, 98053
Work Model:
Hybrid – 4 days onsite, 1 day remote
Shift: 8 AM – 5 PM PST, Monday–Friday
Employment Type:
Temporary (Full‑Time)
Estimated Duration: 13 months
Hourly Rate: $70.00–$75.00 per hour
Role OverviewSupports manufacturing operations and suppliers, leading investigations of nonconformities, CAPAs, complaints, and driving process and product quality improvements.
Responsibilities- Investigate, document, and resolve nonconformances and CAPAs within Track Wise and related systems.
- Lead root‑cause analysis and resolve quality issues for internal and supplier‑driven defects.
- Collaborate cross‑functionally with operations, engineering, regulatory, compliance, and suppliers to manage corrective actions and improvements.
- Support manufacturing transfer activities and manage supplier‑initiated change requests (SICR) and Supplier Corrective Action Requests (SCAR).
- Develop and improve manufacturing and distribution processes, including PPAP, PFMEA/DFMEA, control plans, and process flow diagrams.
- Participate in, or lead, the creation or review of new or modified procedures, validation protocols, and equipment qualification.
- Maintain KPIs for process/product quality, analyze trends, and trigger appropriate actions.
- Assist in reviewing validation protocols, reports, process and equipment validation, label reviews, change orders, and documentation (including MSA).
- Perform other related duties as assigned.
- Bachelor’s degree in Engineering.
- 5+ years in quality engineering within a manufacturing or regulated industry.
- Experience investigating nonconformances, CAPAs, and quality issues.
- Proficiency in Track Wise, SAP, Master Control, or equivalent quality systems.
- Project management and compliance risk experience.
- Experience interacting with regulatory agencies.
- Strong root‑cause analysis skills.
- Excellent communication abilities; ability to explain resolution plans and lead stakeholder discussions.
- Capable of working independently and collaboratively.
- Thrives in stressful, time‑sensitive situations.
- Medical device experience.
- Experience in a regulated industry.
- PPAP execution.
- Validation experience.
- DFMEA/PFMEA expertise.
- Control plans, process flow diagrams.
- Ability to define requirements and collect objective evidence.
- Track Wise – nonconformances, CAPAs, complaints.
- Master Control – document management.
- SAP – order management, holds, manufacturing systems.
Only those lawfully authorized to work in the United States will be considered.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender expression or identity, national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California, will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance completing this application or during any phase of the application, interview, hiring, or employment process, including due to a disability, please contact our HR Department.
Rose International has an official agreement (), effective June 30 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E‑Verify). (Posting required by OCGA 13/10-91.)
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