My client is a Medical Device company looking to expand their presence in the region.
This role will be responsible for leading and driving the Product Quality and Supplier Quality Management activities within Singapore. This will include support for new product development and transfers.
Responsibilities:
- Maintain and comply with the requirements of IS013485, GMP, FDA 21 CFR Part 820 and other applicable regulations.
- Participate in the internal and notified body audit programs as required.
- Management of MRR activities.
- Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections
Requirements:
- Degree in Engineering or equivalent, with 8 - 12 yrs of progressive Quality responsibility in medical device manufacturing.
- Excellent communication & project management skills.
- Team management skill would be added advantage.
- Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc.
- Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
If you are looking to develop your career alongside a reputable organization, please apply with your CV.
