- Medical devices manufacture with amazing 40% expansion plans in place
- Challenging and fast-paced work environment with extensive exposure to learning opportunities
- Vibrant, motivated and cohesive team
I am collaborating with a class III/IV medical devices manufacturer, assisting them to actively search for a senior quality engineer for their new product manufacturing. You will be leading quality and compliance projects, ensuring performance and safety of manufactured components according to cGMP and QMS specifications.
What's on offer?
- Minimum 3 months of overseas training to familiarize with the new product manufacturing process
- Good opportunities in career progression
- You get the chance to learn the ropes directly from the quality director himself
- 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
- Work effectively 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
- Bachelor's degree in mechanical, biomedical, polymer engineering, natural sciences or equivalent disciplines
- At least 5 years of work experience in a highly regulated manufacturing setting
- Knowledge of FDA's QSR and ISO 13485, ISO 14971 is preferred
- Strong knowledge in utilizing statistical analysis tools and quality techniques, such as SPC, DoE, DFSS, DMAIC, FMEA (design/process), Gage R&R
- Prior experience in NPI will be a plus point
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).