My client is a global name in the medical device sector and is recruiting for an R&D Quality/Design Assurance Engineer to support new product development and product maintenance.
- Global Name
- Innovative Products
- Attractive Remuneration
- Ensure that all design control and production / process control projects meet applicable regulatory and corporate standards.
- Handle projects and tasks from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards
- Develop quality plans, execute inspection & testing activities and work with Manufacturing on the transfer of quality requirements.
- Develops and review product verifications and validation test plans.
- Review product reliability specifications and conduct risk management activities including failure mode effects analysis (FMEA), hazard analysis, fault tree analysis (FTA) etc.
- Participate in product or process design and change activities, including design reviews.
- Apply Design to Cost and Design for Manufacturability methods to support leaders in achievement of project objectives.
- Ensure proper design and development documentation as per ISO 13485/FDA Standards.
- Create and implement changes to ensure strict compliance with FDA Standards.
- Ensure a safe, healthy, and environmentally friendly workplace by observing procedures and ISO 14001 regulations.
- Advanced Degree in Biomedical, Electrical, Mechanical, Polymer, Sciences or equivalent
- 5-7 years' work experience in a Product Development/Design Assurance/R&D Quality function in the medical device/biotech sector
- Experience in the design and development of products in accordance with ISO 13485.
- In depth know-how and experience of quality techniques: DFSS, DoE, FMEA, etc.
- Knowledge in manual assembly processes, involving silicone and molded/extruded parts.
- Experience in the entire Design life cycle and Phase-Gate development process.
- Experience with SAP/MES Systems will be a plus.
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).