Position Description

QA Engineer (Medical Devices, West)
Job Code 15499
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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The Role

This position is responsible to provide quality engineering support for the manufacture of the medical devices throughout the supply chain. Focusing on performing Validation Process review and Risk Management Able to use the appropriate statistical techniques and quality tools to ensure medical devices are made in compliance with QMS, International/ industry standards, regulatory requirements and customer requirements

 

Responsibilities

  • In charge of risk management process, maintain risk management procedure and risk management framework. Responsible for all risk assessment report review, review risk management plan/report for all products platform
  • Manage multiple projects to provide review on technical validation of analytical tests, control systems, utilities and manufacturing processes
  • Driving overall quality performance and compliance throughout the organization by defining, implementing validation program
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products
  • Drive manufacturing process improvement project to resolve quality, yield or cost reduction initiatives driven by the organization
  • Provide guidance or training on use of risk management tools and techniques, data analysis, sample size determination, problem solving methods and statistical control techniques
  • Execute projects and other duties that determined by supervisor

 

Requirements

  • Bachelor degree or diploma in science or engineering field
  • At least 3 years of experience in a medical device/ pharmaceutical industry and/ or relevant experience in quality assurance management
  • Strong fundamentals in quality assurance principles
  • Knowledge and working application of validation principles and guidelines and industry practice
  • Knowledgeable in ISO 9001, ISO 13485 and/ or 21 CFR Part 820 regulations
  • Able to communicate across functional team on guidance for validations, risk assessments, and statistical techniques

Contact Person: Wong, Tiing Hua - Reg No:R1328106 (tiinghua.wong@gmprecruit.com)

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