Quality Assurance (QA) Manager – Chinese GMP, ISO 13485 and FDA 21 CFR Part 820 Implementation
Inpeco
- China
- Permanent
- Full-time
- Lead QMS Implementation: Design, implement, and manage our Chinese GMP, ISO 13485, and FDA 21 CFR Part 820 Quality Management System, ensuring readiness for audits and regulatory inspections.
- Oversee QMS Processes: Take charge of essential QMS processes, including document control, CAPA, internal audits, nonconformance management, supplier quality, and change control.
- Enhance Product Quality: Collaborate closely with QC and production teams to establish robust product inspection and testing procedures, ensuring alignment with all quality requirements.
- Manage Inspections & Testing: Ensure accurate and timely execution of incoming, in-process, and final product inspections, with prompt resolution of any nonconformities. Develop and implement procedures for sampling, testing, and release of raw materials, components, and finished products.
- Maintain Equipment Integrity: Ensure proper use and maintenance of inspection tools and equipment, including meticulous calibration management.
- Drive Cross-Functional Collaboration: Partner with Manufacturing, R&D, Regulatory Affairs, and Engineering teams to resolve quality issues and drive continuous process improvements.
- Lead Risk Management: Support and lead risk management activities in accordance with ISO 14971.
- Analyze & Report: Analyze and report on key QA and QC metrics, recommending actionable plans for improvement.
- Manage Audits: Manage and/or support external audits and regulatory inspections (e.g., NMPA, Certification Bodies, FDA).
- Train & Develop: Train and coach staff on critical quality procedures and regulatory requirements.
- Innovate Systems: Evaluate and implement electronic QMS and QC systems to enhance efficiency and compliance.
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- Master’s degree preferred.
- 5–10 years of progressive experience in Quality Assurance and/or Quality Control roles within the medical device industry, preferably in an international context.
- Proven track record of successful ISO 13485 and FDA 21 CFR Part 820 QMS implementation or oversight.
- In-depth knowledge of:Chinese GMP
- ISO 13485
- FDA 21 CFR Part 820
- ISO 14971
- EU MDR/IVDR (a strong plus)
- ISO 13485 Lead Auditor
- Native Chinese speaker required.
- Excellent written and spoken English is essential.
- Must be capable of writing precise technical documents and effectively communicating with auditors, regulators, and global teams.
- Quality System Expertise: Demonstrated expertise in designing, implementing, and maintaining quality systems that meet international standards.
- Audit & Problem-Solving Skills: Skilled in audit planning, root cause analysis, and effective corrective/preventive action implementation.
- Regulatory Acumen: Ability to interpret and practically apply complex regulatory requirements within a manufacturing environment.
- QC Methodologies: Strong knowledge of QC methodologies, including statistical sampling, AQL, visual and dimensional inspection, and functional testing.
- GMP & Testing Protocols: Familiarity with GMP, robust inspection protocols, and test method validation.
- Equipment & Measurement Systems: Understanding of calibration, equipment qualification, and measurement system analysis (MSA).
- QC Leadership: Experience in managing or effectively collaborating with QC inspectors and lab staff.
- Troubleshooting: Capable of troubleshooting quality issues on the production floor and implementing immediate containment and long-term corrective actions.
- Leadership & Influence: Strong leadership and interpersonal skills, with the ability to influence stakeholders and build cross-functional alignment.
- Analytical & Pragmatic: Highly organized, analytical, and quality-focused, with a pragmatic approach to problem-solving.
- Adaptability: Comfortable thriving in a dynamic, fast-paced environment while effectively managing multiple priorities.