I am collaborating with a Class III medical devices manufacturer with amazing expansion plans in place for the next couple of years. They are looking for an independent and highly-driven Senior Quality Engineer to support the operational quality activities on the line. You will be working in a fast-paced, challenging environment with like-minded, motivated and vibrant individuals.
What will you be doing?
- Assume the role of a technical lead, developing and implementing quality related projects (e.g. continuous improvement projects)
- Provide quality advice and guidance to all teams in relation to manufacturing to achieve established quality goals
- Effectively work cross-functionally to resolve non-conforming issues and apply RCA and failure investigations to drive CAPA according to quality standards.
- Oversee process validation programs to access and ensure validation and documentation is sufficient according to regulatory compliance and statistical guidelines
What you will bring to the role:
- Bachelor's degree in mechanical, biomedical, polymer engineering or equivalent disciplines
- At least 5 years of work experience in a highly regulated manufacturing setting. Prior experience in supervisory activities will be preferred.
- Strong knowledge of FDA's QSR and ISO 13485, ISO 14971 will be an added advantage
- In-depth knowledge in Six Sigma methodologies, SPC, Gage R&R, FMEA, root cause analysis and other related quality techniques.
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).
