Position Summary
The QC Supervisor is responsible for overseeing day-to-day quality control operations to ensure that all medical devices meet internal specifications, customer requirements, and regulatory standards (ISO 13485, GMP). This role supervises QC staff, ensures timely inspection and testing of materials and finished products, manages documentation, and supports continuous improvement of quality systems.
1. QC Operations & Supervision
- Lead, train, and supervise QC inspectors/technicians.
- Plan and allocate daily inspection/testing activities for incoming materials, in-process production, and finished goods.
- Ensure adherence to approved inspection procedures, work instructions, and sampling plans.
- Monitor QC lab/inspection area and ensure proper calibration and maintenance of equipment.
2. Compliance & Documentation
- Ensure QC activities comply with ISO 13485, GMP, and internal SOPs.
- Review and approve QC records, inspection reports, test results, and COAs.
- Maintain accurate documentation for audits, CAPA investigations, non-conformities, and change controls.
- Handling internal and external audits (ISO13485, GMP, notified bodies, customer audits).
3. Quality Issue Management
- Lead investigations of non-conforming materials and products.
- Initiate NCRs, participate in root cause analysis, and contribute to corrective/preventive actions.
- Communicate quality issues to production, engineering for timely resolution.
4. Continuous Improvement
- Identify gaps in QC processes and recommend improvements for efficiency and compliance.
- Support implementation of statistical techniques for process monitoring
- Contribute to validation activities (process, equipment, test method validation).
5. Cross-Functional Collaboration
- Coordinate with Production, Engineering, Supply Chain, and R&D to ensure quality standards are met.
- Provide inputs for supplier quality issues and qualification when needed.
- Support new product development
