Our client, a leading medical device company, has engaged GForce Life Sciences to provide a Quality Engineer to support manufacturing operations and supplier quality activities. This role will focus on investigating non-conformances, driving root cause analysis and corrective actions, and supporting process improvements and validation activities. The ideal candidate has strong manufacturing quality experience, excellent problem-solving skills, and the ability to lead cross-functional teams in a fast-paced, regulated environment.

Responsibilities

- Partner with Operations, Engineering, Regulatory, Compliance, and suppliers to maintain product and process quality.
- Own and manage internal and supplier-driven non-conformances (NCs) and Corrective and Preventive Actions (CAPAs), ensuring timely investigation, resolution, and closure within TrackWise.
- Lead root cause investigations and cross-functional problem-solving efforts to address quality issues and prevent recurrence.
- Investigate and disposition non-conforming products, support Material Review Board (MRB) activities, and coordinate containment actions when manufacturing issues arise.
- Support manufacturing-related complaint investigations and product field actions.
- Manage supplier quality activities, including Supplier Corrective Action Requests (SCARs), Supplier Initiated Change Requests (SICRs), and supplier-related process changes.
- Lead and support Production Part Approval Process (PPAP) activities related to supplier changes.
- Support manufacturing transfers between facilities and identify opportunities for supplier part certification.




- Participate in process improvements, change management, and the development of manufacturing and distribution processes.
- Review and support process and equipment validation/qualification protocols, reports, and Measurement System Analysis (MSA) activities.
- Review quality documentation, including procedures, change orders, labels, and validation records.
- Monitor quality KPIs, analyze trends, and recommend actions to improve product quality and manufacturing performance.

Qualifications

- Bachelor's degree in Engineering or a related scientific discipline.
- 3+ years of Quality Engineering or related quality experience.
- Strong root cause analysis and problem-solving experience; formal RCA methodologies preferred.
- Experience supporting manufacturing quality and working cross-functionally with Operations and Engineering.
- Experience with process and equipment validation and reviewing validation documentation.
- Ability to manage multiple priorities, work independently, and make decisions in a rapid-paced manufacturing environment.
- Strong communication skills, with the ability to lead discussions, influence stakeholders, and clearly communicate resolution plans.
- Highly organized, detail-oriented, and comfortable working through time-sensitive quality issues.
- Experience in a regulated industry required; medical device or aerospace experience strongly preferred.
- Familiarity with TrackWise, MasterControl, and SAP is beneficial.
- Knowledge of PPAP, DFMEA/PFMEA, Control Plans, and Process Flow Diagrams is a plus.

📌 Senior Quality Assurance Engineer (Redmond)
🏢 GForce Life Sciences
📍 Redmond