Senior Engineer, Quality Assurance Engineering - 536-1
About The Position
We are seeking a Senior Quality Assurance Engineer to join a dynamic manufacturing quality team supporting both production operations and supplier quality. This role is ideal for someone who enjoys solving complex problems, leading cross-functional initiatives, and making a direct impact on product quality in a fast-paced manufacturing environment. As a key member of the Quality Engineering team, you'll work closely with Manufacturing, Operations, Engineering, Regulatory, Compliance, and Suppliers to investigate quality issues, drive corrective actions, improve manufacturing processes, and ensure products consistently meet quality and regulatory standards. If you're naturally curious, thrive under pressure, and enjoy leading root cause investigations, we'd love to hear from you.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or another technical discipline (or equivalent experience).
- Experience in Quality Engineering within a manufacturing or regulated industry.
- Strong experience investigating non-conformances and performing root cause analysis.
- Experience managing CAPAs and quality investigations.
- Excellent communication and stakeholder management skills.
- Ability to lead cross-functional teams and influence decisions.
- Comfortable working in a fast-paced manufacturing environment with shifting priorities.
- Strong analytical and problem-solving abilities.
Nice To Haves
- Medical device or life sciences industry experience.
- Manufacturing floor experience.
- Experience with validation activities and process improvements.
- Knowledge of PPAP, DFMEA, PFMEA, Control Plans, and Process Flow Diagrams.
- Experience with TrackWise, MasterControl, and SAP.
- Familiarity with FDA, ISO, or other regulated quality systems.
Responsibilities
- Investigate and resolve product and process quality issues, including non-conformances (NCs) and CAPAs.
- Lead root cause analysis and facilitate cross-functional problem-solving sessions.
- Own quality records and ensure timely processing and closure within TrackWise.
- Partner with manufacturing teams during line-down situations to quickly identify issues and restore production.
- Support complaint investigations, product field actions, and material review board (MRB) activities.
- Collaborate with suppliers to resolve quality concerns, manage Supplier Corrective Action Requests (SCARs), and evaluate supplier change requests.
- Review and support Production Part Approval Process (PPAP) activities for supplier changes.
- Drive continuous improvement initiatives focused on manufacturing efficiency, product quality, and process performance.
- Support process, equipment, and validation activities, including validation protocols, reports, and Measurement System Analysis (MSA).
- Review quality documentation, change orders, and labeling changes.
- Monitor quality metrics, analyze trends, and recommend improvements.
- Participate in the development and revision of quality procedures and manufacturing processes.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
