QA Engineer (ID6006)

Electronic product manufacturing company

Singapore

SGD 80,000 - 100,000

Job description

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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 Engineering
At least 3 years of working experience in Quality Management System, and in Electronic manufacturing Industry
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