Quality Supervisor
3 days ago
We are hiring an experienced Quality Control Supervisor to lead our quality inspection department within a regulated medical device extrusion facility. This is a strategic leadership role responsible for overseeing inspection personnel, ensuring adherence to regulatory standards (ISO 13485, FDA, GMP), and continuously improving quality systems. You'll act as the primary quality liaison for production, supporting cross-functional teams to ensure that extruded tubing meets the highest standards. The ideal candidate combines technical depth in quality systems with strong leadership, coaching, and decision-making skills. This role is key to ensuring compliance, driving performance, and supporting operational excellence.
- Supervise and coordinate QC team activities across all shifts, including inspectors and leads.
- Ensure compliance with ISO 13485, FDA regulations, and internal quality policies.
- Review and approve quality records, batch documentation, and non-conformance reports.
- Lead investigations and corrective/preventive actions (CAPA) for quality issues.
- Support internal and external audits, including FDA and ISO inspections.
- Collaborate with Engineering and Production to improve process capability and reduce defects.
- Maintain calibration schedules and oversee use of inspection equipment.
- Monitor production trends and quality metrics (scrap rates, yield, complaints).
- Manage inspector training and development plans.
- Implement and enforce GMP practices and cleanroom compliance.
- Lead or assist with risk assessments and validations (IQ/OQ/PQ).
- Contribute to continuous improvement projects and lean initiatives.
- Manage department scheduling, resource allocation, and shift coverage.
- Ensure timely release of conforming product and resolution of quality holds.
- Participate in change control processes and documentation updates.
- Associates degree is a technical field required, bachelor's degree in engineering, life sciences, or a related field preferred.
- 5+ years of experience in a regulated quality or engineering role, with at least 2 years of supervisory experience.
- Deep understanding of ISO 13485, FDA 21 CFR Part 820, and GMP.
- Prior experience in plastic extrusion or medical device manufacturing strongly preferred.
- Excellent leadership, communication, and problem-solving skills.
- Familiarity with QMS software, SPC, and root cause tools (e.g., 5 Whys, Fishbone, 8D).
- Working knowledge of ERP/MES systems (e.g., SAP, Oracle, IQMS).
Familiarity with cleanroom protocols and medical-grade manufacturing environments.
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