Senior Quality Assurance Engineer

• 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 fast-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.