Job duties:
- Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
- Develops and leads quality assurance function/team and QMS quality planning process
- Co-ordinate with various functions to ensure awareness and understanding of the Quality
- Ensures operational process operating and meeting process/ product requirement/ specification
- Ensure that the procedures and processes prescribed by the Quality Management System are in place and implemented per requirement
- Arrange for ISO13485, ISO14971 and FDA 21 CFR Part 820 awareness training and further refresher training as needed
- Able to travel for suppliers / customer visits
Requirements:
- Bachelor’s Degree in Quality Management or Electronics/Mechatronics Engineering
- At least 3 years of working experience in Quality Management System, and in manufacturing environment
- Excellent hands on knowledge of Quality Management System primarily in ISO 13485 and FDA 21 CFR Part 820
- Establish controls system required in ISO13485 & FDA registered facility
