- General
- China - Shenzhen
Quality Manager - Medical Devices
Our client is a global medical device specialist focusing on high-end Class III implantable clinical solutions with solid technical advantages in its niche market. Supported by long-term market layout in China, the group is building a fully localized greenfield manufacturing subsidiary covering production, quality control, distribution and regulatory compliance, with all operations strictly aligned with NMPA and China Medical Device GMP standards.
We are exclusively mandated to recruit a Quality Manager for this newly established site. This core quality leadership role will build the full local quality management system, own end-to-end GMP compliance, batch release and supplier quality governance, and serve as the key interface linking local plant, global quality team and domestic regulatory authorities.
Reporting to: Global Regulatory & Quality Director / China Industrial Project Director
Location: Shenzhen, China
KEY MISSIONS & RESPONSIBILITIES
This role takes full ownership of the site’s Quality Management System (QMS), manufacturing compliance and finished product batch release. You act as the core bridge between internal production teams, global quality & regulatory functions and NMPA authorities, bearing full accountability for all onsite quality compliance execution.
QMS Construction & Sustained Maintenance
Develop and roll out a localized QMS matching the new plant’s operational needs; ensure the system stays fully compliant with China Medical Device GMP at all times.
Full Document Control & Traceability
Own all site compliance documents; guarantee accuracy, validity and complete archiving of quality SOPs, GMP records to realize full traceability.
Quality Operation & Continuous Improvement
Oversee full-cycle CAPA implementation, deviation handling and change control processes; drive plant-wide continuous quality optimization.
Batch Release & Product Compliance Governance
???????Complete full compliance verification before batch release; strictly follow NMPA requirements to authorize finished product release and take primary responsibility for all released batches.
Supplier Quality Management
???????Lead quality supervision for domestic and overseas suppliers; conduct regular supplier audits to ensure full GMP compliance across the supply chain.
Post-Market Surveillance & Risk Handling
???????Manage customer quality complaints, adverse event reporting and full product recall workflows when quality risks emerge.
Regulatory Communication & Statutory Reporting
???????Compile and submit all mandatory quality reports to medical regulators; complete all regulatory filings within legal deadlines.
INTERNAL & EXTERNAL STAKEHOLDERS INTERACTIONS
Internal
???????Report directly to China General Manager and Global Regulatory & Quality Director; conduct regular cross-functional alignment with global quality teams (regular overseas travel required); lead all internal site quality audits across departments.
External
???????Serve as the official corporate representative for all NMPA onsite inspections; liaise with third-party audit bodies and certification institutes; execute onsite quality audits at upstream suppliers and subcontractors.
REQUIRED KNOWLEDGE, SKILLS & COMPETENCIES
- Bachelor’s degree or above in Pharmacy, Engineering, Life Sciences, Quality Management or other relevant technical disciplines.
- Minimum 8 years hands-on QA experience in medical device manufacturing.
- Mandatory track record acting as Management Representative or Product Release Responsible at medical device manufacturers.
- Prior quality management experience for Class III active or implantable medical devices is highly preferred.
- Practical end-to-end mastery of China Medical Device GMP framework; expert knowledge of NMPA rules on product batch release and post-market vigilance.
- Meticulous, rigorous and standards-driven with strict control over documentation and procedural compliance; capable of delivering objective, precise communication on quality risks and corresponding solutions.
- Professional business English for daily technical communication and cross-border reporting (mandatory).
INFORMATION & APPLICATION
If you are interested in and qualified for this position, please feel free to get in touch via sarah.zhang@talent-fishers.com and share your resume for the “Quality Manager” job application.
Suitable candidates will be contacted within one month upon application.