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.
