Job Description

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

Requirements:

• 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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