Quality Engineer – Medical Mfg Ind. (Software Validation / UAT/ 5 days) TJY

MNC, Medical Manufacturing Industry
Location: East area, island wide transportation provided
5 days’ work week
Responsibilities:
  • Ensure the manufacturing processes comply with the product specification and regulatory government agencies requirements.
  • Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products.
  • Develop overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
  • Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.
  • Document that processes complies, with a high confidence level, the tolerances stated on the product specification and drawings.
  • Evaluate product/material discrepancies and implement corrective actions accordant.
  • Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers.
  • Update manufacturing processes in order to reflect quality concepts and specification requirements.
  • Apply statistical tools in order to assure that processes comply with the specifications.
  • Ensure compliance to audit findings in a timely manner.
  • Conduct failure investigations in order to initiate, stimulate, and assign corrective action. Issue written reports and update, accordingly.
  • Develops, modifies, applies, and maintains standards for quality operating methods, processes, systems and procedures related to software applications and ensure compliances to corporate and regulatory level.
  • Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
  • Reviews and approve software design, change specifications, and plans against contractual and/or process requirements.
  • Performs or directs verification of software requirement allocations, traceability, and testability.
  • Review and approve software test plans and procedures and oversees all applicable compliance related to manufacturing software.
Responsibilities:
  • Diploma / Bachelor Degree in Engineering, Information Management, Computer Sciences or relevant experience.
  • 3 years’ experience in Engineering related to manufacturing (medtech / pharma industry) environment (prefer QA functions experience)
  • Capability to recognize problems, causes, and solutions
  • Experience in software validation, UAT and documentation of test cases will be added advantage
  • Familiar with FDA 21 CFR Part 11 will be advantageous
Interested candidates, please state last / expected salaries and notice period and email to: main@todaycareer.com.sg
TODAY’S CAREER PTE. LTD.
10 Anson Road International Plaza  #30-13
Singapore 079903
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Website: www.todaycareer.com.sg
Email: main@todaycareer.com.sg
(Team members for this post :Katheriene Ang/ Charis Heng/ Lim Jia Ying)
Registration Number : R1102123/ R1329943/ R1549375)
Only shortlisted candidates will be notified. Let us call you when we are ready.
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