Senior Quality Assurance Engineer

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-Month Contract

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 TrackWise.
• 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.

Requirements And Qualifications

• 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 TrackWise 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.