Position Title - QC Supervisor

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.
QC Operations & Supervision

Monitor QC lab/inspection area and ensure proper calibration and maintenance of equipment.
Lead, train, and supervise QC inspectors/technicians.
Ensure adherence to approved inspection procedures, work instructions, and sampling plans.
Plan and allocate daily inspection/testing activities for incoming materials, in- process production, and finished goods.

Compliance & Documentation

Review and approve QC records, inspection reports, test results, and COAs.
Handling internal and external audits (ISO13485, GMP, notified bodies, customer audits).
Ensure QC activities comply with ISO 13485, GMP, and internal SOPs.
Maintain accurate documentation for audits, CAPA investigations, non- conformities, and change controls.

Quality Issue Management

Lead investigations of non- conforming materials and products.
Communicate quality issues to production, engineering for timely resolution.
Initiate NCRs, participate in root cause analysis, and contribute to corrective/preventive actions.

Continuous Improvement

Support implementation of statistical techniques for process monitoring
Identify gaps in QC processes and recommend improvements for efficiency and compliance.
Contribute to validation activities (process, equipment, test method validation).

Cross- Functional Collaboration

Provide inputs for supplier quality issues and qualification when needed.
Support new product development
Coordinate with Production, Engineering, Supply Chain, and R&D to ensure quality standards are met.

Familiarity with CAPA, NCR, calibration, and 3Q- validation processes.
Proficiency in MS Office; experience with QMS software is an advantage.
Supervisory or team- lead experience preferred.
Strong knowledge of ISO 13485, GMP, and risk management
3–5+ years of experience in Quality Control within the medical device or pharmaceutical industry.
Experience with measurement tools, inspection techniques, and QC testing equipment.
Bachelor’s degree in Science, Engineering, Pharmacy, or related field.
Strong analytical, communication, and leadership skills.
Candidates currently living or able to live long- term in Hai Phong- proximity to the company is an advantage

Chế độ bảo hiểm, Du Lịch, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương

Cập nhật gần nhất lúc: 2025-12-30 12:00:10