Quality Assurance (QA) Manager – Chinese GMP, ISO 13485 and FDA 21 CFR Part 820 Implementation

Would you like to work in a technological company dedicated to the development of medical solutions?

Inpeco is the world leader in the automation of clinical laboratories, where we create innovative robotic solutions to manage biological samples. Our systems reduce the possibility of human error, limit the risks of contamination and guarantee complete traceability of the sample.

Our solutions support over 2.700 clinical laboratories worldwide.

The Inpeco Group has its headquarters in Novazzano (Switzerland), a production plant in Val della Torre (Torino), a site dedicated to Innovative Projects in Pula (Sardinia), a small site in Verona and five reference locations for the foreign market in Brussels (Belgium), United States, Germany, France and Spain.

What are you waiting for? Come join the Inpeco team and innovate with us!

Position:

Location: China -Jiangyin

Employment Type: Full-Time

Department: Quality Assurance

Reports To: Board of Directors

Are you an experienced and proactive Quality Assurance (QA) Manager with a strong background in medical device quality systems? We're looking for a leader to spearhead the development and implementation of a fully compliant Quality Management System (QMS) covering Chinese GMP, ISO 13485, and FDA 21 CFR Part 820.

In this pivotal role, you'll also oversee or coordinate Quality Control (QC) activities, ensuring our products consistently meet stringent specifications and regulatory requirements. If you're passionate about fostering a culture of continuous improvement and compliance within a dynamic medical device environment, we encourage you to apply!

What You'll Do:

• 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.

Requirements:

Education:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• Master’s degree preferred.

Professional Experience:

• 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 GMPISO 13485FDA 21 CFR Part 820ISO 14971EU MDR/IVDR (a strong plus)

Certifications (preferred):

• ISO 13485 Lead Auditor

Language Proficiency:

• 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.

Other information:

Key Competencies:

• 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.