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quality engineer

Address: No.1,Tengfei Road, Guli Industrial Park, Changshu, Changshu, Jiang Su Sheng 215533, China

Job ID: R0274552

Location Type: Onsite

Job Overview

As an Engineer at Fresenius Medical Care, you will be a vital part of developing medical devices that deliver exceptional kidney care to patients around the world. Working across disciplines from Research and Development, Quality, Manufacturing, or Software, your expertise will support medical technologies used by patients and healthcare teams every day. Here, engineering is more than a job — it's a chance to advance healthcare innovation that makes a real impact on people's lives.

A healthcare worker in protective clothing holds hands and smiles at an older patient receiving medical treatment, while another patient sits nearby in a clinic setting.

Job Description

  • 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

Care in every moment.
Connection in every step.

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