Position Description

Senior/QA Validation Engineer (Medical Device MNC/West)
Job Code 15346
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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  • Global Medical Device MNC
  • Work Location: West
  • Multiple vacancies available

 

Responsibilities:

  • Perform Validation Process review and Risk Management
  • Utilize appropriate statistical techniques and quality tools to ensure medical devices are made in compliance with QMS, international/quality standards, regulatory and customer requirements.
  • In-charge of risk management process, maintain risk management procedure and framework.
  • Responsible for all risk assessment report review, review risk management plan/report for all products platform
  • Drive overall quality performance and compliance throughout the organization by defining and implementing validation program
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process control 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 the use of risk management tools and techniques
  • Execute projects and other duties that determined by supervisor

 

Requirements:

  • Degree or Diploma Holder in any relevant science or engineering field
  • At least 3 years QA experience in medical device or pharmaceutical industries;  Strong fundamental knowledge on QA principles
  • Working knowledge on Validation process, principles and guidelines
  • Injection Molding and Sterilization process experience are added advantage
  • Strong fundamental knowledge on QA principles
  • Ability to communicate across functional team on guidance for validation, risk assessment, and statistical techniques.
  • Knowledgeable in ISO 9001, ISO 13485 and/or 21 CPR Part 820 regulations
  • Excellent written and verbal communication
  • Meticulous and detail-oriented
  • Confident to lead a constructive debate about product quality with colleagues and suppliers

 

To apply, please visit to www.gmprecruit.com and search for Job Reference:15346

To find out more about this opportunity, please contact Alexandra Calingo at: alexandra@gmprecruit.com

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: 09C3051

Contact Person: Sy Calingo, Alexandra - Reg No:R1101491 (alexandra@gmprecruit.com)

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