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

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.
Lead, train, and supervise QC inspectors/technicians.
Monitor QC lab/inspection area and ensure proper calibration and maintenance of equipment.

Compliance & Documentation

Maintain accurate documentation for audits, CAPA investigations, non- conformities, and change controls.
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.

Quality Issue Management

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

Continuous Improvement

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

Cross- Functional Collaboration

Support new product development
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.

Bachelor’s degree in Science, Engineering, Pharmacy, or related field.
Supervisory or team- lead experience preferred.
Proficiency in MS Office; experience with QMS software is an advantage.
Strong knowledge of ISO 13485, GMP, and risk management
Strong analytical, communication, and leadership skills.
Experience with measurement tools, inspection techniques, and QC testing equipment.
Familiarity with CAPA, NCR, calibration, and 3Q- validation processes.
3–5+ years of experience in Quality Control within the medical device or pharmaceutical industry.
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: 2026-01-22 02:05:02