Position: QA Engineer
Monthly Salary: $3200 - $5500
Working Location: Serangoon
Working Hours: Monday to Friday 8.30am – 6pm
Responsibilities:
- Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
- Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap
- Manage and oversee quality audits by plan and ensure quality audits findings and recommendations are rectified and implemented. Apprise management of quality audit findings and corrective actions taken
- Ensure that the procedures and processes prescribed by the Quality Management System are in place and implemented per requirement
- Review the Quality Management System periodically to assess continued suitability and areas of possible improvement
- Arrange for ISO13485, ISO14971 and FDA 21 CFR Part 820 awareness training and further refresher training as needed
- Co-ordinate and plan work of external audit such as Customer, ISO certification and Regulatory bodies
- Ensure that systems and procedures are in compliance with ISO13485, ISO14971, FDA 21CFR Part 820, and GDP requirements
- Mentor / supervise as assigned and ensure timely and accurate completion of quality projects Support Plant wide audit/ inspection activities and special projects, as assigned
- 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
- Lead, mentor and facilitate problem solving and quality improvements
- Establish controls system required in ISO13485 & FDA registered facility
- Strong communication and interpersonal skills
- FDA Inspection experience preferred
Registration Number: R1112981
Thong Yie Sze
Inter Island Manpower Pte Ltd (Co Reg: 200810144N/ EA License: 08C3527)
Please send your updated resume by clicking "Apply". Only shortlisted candidates will be notified.
