Quality Assurance Engineer (FDA/ISO13485/Up $5.5k+VB)

Location Singapore
Discipline Engineering
Job Reference BBBH131184_1693968601
Salary S$4500 - S$5500 per month
Consultant Email [email protected]
EA License No. 02C3423

Job duties:

  • 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
  • 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


  • Diploma/Degree in quality or Electronics/Mechatronics or engineering relevant course
  • 3 to 5 years Quality Management System experience from telecommunication manufacturing industry
  • Proficient in ISO13485 & FDA registered facility

5 days work week, office hours
Working location: Serangoon

Tan Lee Fong, Grayson EA License No.: 02C3423 Personnel Registration No.: R1441412

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