Product Development Quality Engineer

Talent Search Pte Ltd| Date Posted: 21-Mar-2020
EA Licence No: 05C5173|EA Personal Registration No: R1102641
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

European client in medical device and tooling design and manufacturing

  • Applied quality engineering control process on all design and production process to meet regulatory requirement
  • Provide quality inputs while participate in new product development and sustaining engineering projects 
  • Develop verification, validation and test plans with manufacturing on transfer of quality requirement
  • Use of statistical methods in the test and quality control measures
  • Conduct risk assessment and management using FMEA, FTA, DOE or other statisical tools 
  • Participate in product design reviews or process design changes 
  • Accountable for proper documentation as per ISO13485, FDA standards

Requirement

  • Degree in Engineering (Material / Polymer Engineering)
  • 5 years of working experience in design and product development of medical devices / laboratory or diagnostic instrument
  • Knowledge of ISO 13485, FDA21 CFR
  • Able to statistical tools / techniques Six Sigma Blackbelt, DFSS, DOE, FMEA
  • Familair with labour assembly manufacturing processes involving polymer, silicon parts would be ideal
  • Knowledge in SAP / MES 
  • May be required to travel pending project scope
  • Work location: Paya Lebar
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Talent Search Pte Ltd