- Identify quality requirements and support design control process and design history files.
- Provide QA related support for new product development and product enhancement.
- Generate or review validation/verification documents, provide support to Quality investigation related to Validation/Verification reject investigation.
- Generate or Update Quality related documents such as Quality Plan, Quality Inspection documents and Lot release Documents during the development phase.
- Coordinate the update of incoming material specs and FAI activities with the Supplier Management Group during the development phase.
- Lead and perform Product Risk Management for current, new/enhanced products.
- Maintain Risk Management Files and Risk Management Plans in accordance to EN ISO 14971.
- Carry out DHR review, returned device decontamination and returned device investigation.
- Responsible for returning of 3rd party complaint products to manufacturers.
- Involve in internal audits, external audits and Quality Assurance related projects when required.
Job Requirements
- Minimum a Bachelor Degree in Mechanical/Industrial/Manufacturing/ Biomedical Engineering related disciplines or equivalent
- At least 1-2 years of medical device experience
- Ability to communicate in English
- Experience in Problem Solving
- Cleanroom/environmental control experience is preferable
- Familiar with ISO 13485, ISO 14971, ISO 25539 and ISO 10555 requirements
- Knowledgeable of applicable cGMP’S, FDA, MDD (93/94/EEC) and MDR (2017/745)
- Knowledge of FMEA, Design Control, Statistical Process Control (SPC) and Problem Solving Tools is preferable
We regret that only shortlisted candidates will be contacted
If interested, please email your resume to [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
