Quality Engineer, Operations

Talent Search Pte Ltd| Date Posted: 2-Sep-2020
EA Licence No: 05C5173|EA Personal Registration No: R1102641
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

MNC - medical device manufacturing setup 

  • Enforce and maintain quality operation procedures for the production site, such as process validation, non-conformance management, engineering change, DMAIC
  • Planning and cooridinate work with internal Microbiologist / external test lab on materials testing and inspection process and reporting 
  • Conduct incoming materials inspection 
  • Generate and review reports on quality issues and change controls
  • Apply six sigma principles and least burdensome approach in quality topics
  • Ensure safety and performance of products manufactured at the site
  • Drive for continuous improvement and CAPA handling
  • Training of quality relevant topics
  • Contacts to suppliers and service providers


Requirement 

  • Bachelor Degree in Mechanical, Biomedical, Engineering or equivalent
  • 5 years of working experience in operations quality field preferably in a medical device manufacturing setup
  • Good knowledge and application of quality metholodgy such as  Six Sigma methods such as DFSS, DMAIC DoE, FMEA, etc.
  • Understand cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
  • Knowledge of statistical methods and able to conduct technical training
  • Willing to work in Eunos area
Company Overview
Talent Search Pte Ltd