Job Details

About the Company: A implantable medical device company seeking expertise in the technical and application areas described in this position. The role offers a focused setting for translating specialist knowledge into research, engineering or organizational outcomes.

Target Candidates: Bachelor’s degree or above in Biomedical/Medical Device Engineering, Quality or Regulatory Affairs.

Responsibilities

•  Rebuild the quality management system for Class III active implants under FDA QMSR, ISO 13485, MDSAP and NMPA requirements.

•  Lead design controls and risk management for DBS products under ISO 14971 across R&D, production, clinical and postmarket phases.

•  Establish production quality controls for incoming inspection, in-process checks and release under applicable US requirements.

•  Implement CAPA, routine quality review and continuous improvement for FDA inspection readiness.

•  The position links scientific or clinical needs with development, testing and application of the relevant technology. The work calls for careful documentation of evidence and coordination among research, product, quality or clinical colleagues as the project requires.

Requirements

•  Bachelor’s degree or above in Biomedical/Medical Device Engineering, Quality or Regulatory Affairs.

•  At least 20 years in medical-device quality systems; US FDA Class III active implant experience preferred.

•  Expertise in FDA QMSR/QSR, ISO 13485/14971, MDSAP, PMA and NMPA, with inspection, CAPA and high-risk implant experience.

Highlights & Support: Annual compensation: RMB 700,000–980,000, subject to final discussion; scope includes FDA international registration and quality-system upgrade.