Position Title - QC Supervisor
Mô tả công việc
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
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.
Compliance & Documentation
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.
Review and approve QC records, inspection reports, test results, and COAs.
Quality Issue Management
Communicate quality issues to production, engineering for timely resolution.
Lead investigations of non- conforming materials and products.
Initiate NCRs, participate in root cause analysis, and contribute to corrective/preventive actions.
Continuous Improvement
Support implementation of statistical techniques for process monitoring
Contribute to validation activities (process, equipment, test method validation).
Identify gaps in QC processes and recommend improvements for efficiency and compliance.
Cross- Functional Collaboration
Support new product development
Provide inputs for supplier quality issues and qualification when needed.
Coordinate with Production, Engineering, Supply Chain, and R&D to ensure quality standards are met.
Yêu cầu công việc
Familiarity with CAPA, NCR, calibration, and 3Q- validation processes.
Supervisory or team- lead experience preferred.
Experience with measurement tools, inspection techniques, and QC testing equipment.
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.
Bachelor’s degree in Science, Engineering, Pharmacy, or related field.
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
Quyền lợi
Chế độ bảo hiểm, Du Lịch, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương
Cập nhật gần nhất lúc: 2026-01-07 07:10:02

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