Senior Quality Assurance Engineer
Listed on 2026-09-13
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Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Quality Control - QC Analysts/Managers
Position Summary
Our client, a leading medical device company, is seeking a Senior Quality Assurance Engineer to support product and process quality within a manufacturing environment. This role will focus on non-conformances, CAPA, supplier quality, corrective actions, process improvements, validation, and quality data analysis. The Quality Engineer will work closely with Operations, suppliers, and cross-functional teams to investigate quality issues, implement corrective actions, and improve manufacturing processes.
18-MonthContract Onsite 4 Days/Week in Redmond, WA Must Be Able to Work on a W2 Position Summary
Our client, a leading medical device company, is seeking a Senior Quality Assurance Engineer to support product and process quality within a manufacturing environment. This role will focus on non-conformances, CAPA, supplier quality, corrective actions, process improvements, validation, and quality data analysis. The Quality Engineer will work closely with Operations, suppliers, and cross-functional teams to investigate quality issues, implement corrective actions, and improve manufacturing processes.
Responsibilities- Work closely with Operations and business functions to ensure quality performance of products and processes.
- Own internal and supplier-driven Non-Conformances (NCs) and CAPAs, managing timely processing and closure within Track Wise.
- Collaborate with internal cross-functional and supplier teams to address top quality issues.
- Support manufacturing-related complaint investigations and product field actions.
- Investigate and disposition internal non-conforming product through MRB and issue NCs as appropriate.
- Communicate and collaborate with suppliers regarding non-conformances and
** escalate
* * Supplier Corrective Action Requests (SCARs) as needed. - Manage Supplier Initiated Change Requests (SICRs), coordinating with cross-functional teams for assessment and approval.
- Support manufacturing transfers between plants and facilities by executing appropriate quality activities.
- Identify and support opportunities for supplier part certification and supplier quality improvement.
- Support the development and improvement of internal manufacturing and distribution processes.
- Evaluate internal and supplier-proposed changes, including PPAP activities related to supplier changes.
- Participate in or lead the creation and review of new or modified procedures.
- Support process and equipment validation/qualification and Measurement System Analysis (MSA) activities.
- Maintain quality KPIs, analyze data, and identify trends in product and process quality.
- Recommend and implement appropriate corrective and preventive actions based on quality trends and data.
- Perform other related duties as assigned.
- Bachelor's degree in Engineering or equivalent technical discipline.
- 3+ years of Quality Engineering experience.
- Experience with Non-Conformances, CAPA, corrective actions, and root cause investigations.
- Experience working with suppliers to resolve quality issues.
- Experience with SCARs and supplier quality activities preferred.
- Experience with Track Wise or a similar electronic quality management system preferred.
- Knowledge of PPAP, change management, process validation/qualification, and MSA.
- Strong analytical skills with the ability to identify trends and make data-driven recommendations.
- Strong attention to detail and sound judgment when evaluating quality issues.
- Ability to work independently with minimal supervision.
- Strong communication and cross-functional collaboration skills.
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