Quality Engineer
Medical Device
Make an Impact in Medical Device Quality
Our client is seeking a Quality Engineer to join our Quality & Regulatory team and play a critical role in maintaining product quality, strengthening quality systems, and supporting continuous improvement.
This is an excellent opportunity for a hands-on Quality Engineer who enjoys working cross-functionally and wants meaningful exposure to manufacturing, engineering, operations, supply chain, suppliers, and contract manufacturers. Reporting directly to the Director of Quality & Regulatory, you'll have the opportunity to make a direct impact on product quality, compliance, and operational excellence.
What You'll Do
- Lead incoming and final inspection activities to ensure materials and finished products meet quality specifications.
- Review and approve Device History Records (DHRs), incoming inspections, product builds, and other quality release activities.
- Manage Nonconformance Reports (NCRs), SCARs, CAPAs, and MRB activities, including disposition of nonconforming materials.
- Conduct root cause analysis and support corrective and preventive actions to drive continuous improvement.
- Manage calibration programs for inspection tools, measuring devices, and test equipment.
- Oversee preventive maintenance schedules and ensure accurate quality and equipment records.
- Execute Engineering Change Orders (ECOs) and maintain controlled documentation through Agile PLM.
- Create, revise, and maintain manufacturing procedures, work instructions, travelers, and other quality documentation.
- Manage employee training records and assignments to ensure compliance with applicable procedures and work instructions.
- Partner with suppliers and contract manufacturers to resolve quality issues, implement corrective actions, and support supplier improvement initiatives.
- Assist with supplier audits and ensure approved changes are properly implemented.
- Collaborate with Engineering, Manufacturing, Operations, Supply Chain, and Quality teams to improve processes and product quality.
What We're Looking For
- Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline preferred.
- Quality Engineering or Quality Assurance experience.
- Experience working in a regulated manufacturing environment, preferably medical devices.
- Strong knowledge of NCR, SCAR, CAPA, MRB, inspection, and quality system processes.
- Experience with calibration, preventive maintenance, document control, and engineering change management.
- Experience with Agile PLM or a similar product lifecycle management system.
- Strong technical writing and documentation skills.
- Excellent analytical, organizational, and problem-solving abilities.
- Ability to work independently while effectively collaborating across multiple functions.
Preferred Experience
- FDA-regulated medical device experience.
- Knowledge of ISO 13485 quality systems.
- ASQ Certified Quality Engineer (CQE) or similar certification.
- Experience conducting supplier audits and working with contract manufacturers.
- Familiarity with Device History Records (DHRs) and medical device manufacturing.
Why This Opportunity?
This is a highly visible role for a Quality Engineer who wants to be more than just a compliance resource. You'll have the opportunity to solve problems, improve processes, influence manufacturing quality, and work directly with cross-functional teams in a regulated medical device environment.
Pay: $90,000.00 - $110,000.00 per year
Work Location: In person
