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).
