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Open nowPosted yesterday

quality engineer

Fersenius Medical Center Inc3,475 open roles

Where
Suzhou, Jiangsu, China
Work mode
On site
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Your applicationOpen nowquality engineerFersenius Medical Center Inc · Suzhou, Jiangsu, China

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Fersenius Medical Center Inc's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Fersenius Medical Center Inc postings stay open a median of 32 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted yesterday

Fersenius Medical Center Inc median: 32 days open

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
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