Job Details

  • ST Recruitment Centre (02C4416)

  • Recruitment Centre

  • QA & Compliance Executive

  • Serangoon

  • $3500-5000

  • 5

  • Deg & above

  • 3

  • REQUIREMENTS:

    Bachelor’s Degree in Quality Management or 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

    DUTIES:

    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

  • Technical/ Engineering/ Production

  • Technical/ Engineering/ Production

  • Permanent


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