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Fresenius Medical Care

quality engineer

Suzhou, Jiangsu, China

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hirly's read of this role

Seniority
Mid level
Country
CN
Work mode
On-site / unstated
First seen by hirly
5 Nov 2026

Derived automatically from the posting. Upload your resume above to see how the role scores against it.

the posting

  • Validation Experts
  • Lead investigations for nonconforming material, in-process failures, complaints and field issues
  • Support new product development / new product introduction to set up validation and process manufacturability
  • Support product transfers and process and product change notifications (design transfer)
  • Performs risk assessments in collaboration with cross-functional teams (pFMEAs)
  • Develop & implement CAPA. Verify & validate CAPA effectiveness
  • Ensure purchased components meet specifications and quality requirements
  • Participate in internal audits and support external audits
  • Support complaint investigations, evaluate returned products & implement feedback loops
  • Analyze quality data, trends, KPIs to drive CI

Job Requirements

  • 5 years’ experience in medical device is desirable
  • Advance knowledge of investigation of NC, CAPA, complaint
  • Advance knowledge of data analysis and relative quality statistic method
  • Advanced knowledge of medical device regulations
  • Advanced knowledge of medical device validation
  • Advanced knowledge of applicable quality management and of risk management standards
  • Knowledge of the design transfer from quality aspect
  • Knowledge of internal and external processes and structures
  • Good in stakeholder management and communication
  • Trusted quality partner in cross-functional project meetings
  • Fluent in English
Original posting on Fresenius Medical Care's site ↗

Listed on hirly, a job board. hirly is not the employer: Fresenius Medical Care is hiring for this role.

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