We are seeking a hands-on Quality Control Manager to lead inspection activities, support quality system compliance, and partner closely with manufacturing teams. This role combines technical quality expertise with leadership responsibilities.
Job Description:
What You'll Do:
- Lead daily quality operations for precision-machined medical device components and assemblies- Review scheduled jobs and verify revisions, specifications, and customer requirements- Develop and maintain inspection plans, processing sheets, and quality documentation- Perform and oversee First Article Inspections (FAIs), in-process inspection, and final inspection processes- Support machinists and production personnel with technical quality guidance- Lead Material Review Board (MRB) activities and disposition decisions- Investigate non-conformances (NCRs), customer complaints, and quality performance- Support corrective and preventative action initiatives- Maintain calibration records, SOPs, and quality documentation- Support ISO 9001 and ISO 13485 compliance through audits and documentation reviews- Train, mentor, and develop inspectors and manufacturing personnel
Required Qualifications:
- 5+ years of quality experience in precision machining, CNC manufacturing, medical device manufacturing, or related environment- Strong blueprint reading and GD&T interpretation skills- Experience performing First Article Inspections (FAIs)- Experience using precision inspection equipment (micrometres, callipers, height gauges, thread gauges, pin gauges, optical inspection
Preferred:
CNC/Swiss machining experience, medical device manufacturing experience, ISO 13485 experience, experience leading quality teams, ASQ certification (CQI, CQT, CQE), Bachelor's degree in Engineering/Manufacturing/Quality
| Location | West Chester, PA |
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