Quality Engineer (Medical Devices)

Location: Singapore
Job Type: Permanent
Specialisation: Life Sciences
Salary: S$5500 - S$7000 per month
Reference: BBBH8358_1594981709
Contact: Kareen Wong
Email: email Kareen

A promising medical devices start-up developing the state-of-the-art medical system is inviting resilient and highly energetic Operational Quality Engineer to join their innovative team.

Responsibilities

  • Ensure product quality and processes are in compliance to company's quality systems regulations and ISO standards
  • Lead root-case analyses and investigations into non-conformance issues, consolidate and present information for filing of CAPA and ensure timely closure
  • Review and approve test protocols with application of appropriate statistical analysis tools
  • Lead in risk assessment and management of all projects.
  • Consolidate quality data, analyzing trends and applying Six Sigma principles in support of continuous improvement initiatives

Requirements

  • A Degree in Engineer (Mechanical/Industrial/Bioengineering) or professional certifications in quality engineering. A Masters degree is preferred.
  • At least 3 years of experience in quality assurance in a manufacturing setting within the medical devices industry.
  • Strong knowledge in ISO 13485, FDA 21 CFR 820, MDD/MDR, ISO 10993 and related medical devices standards
  • Good knowledge of Six Sigma methods and statistical tools (e.g. SPC, Gage R&R, DoE, CPK, pFMEA, etc)

Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).