(W) Quality Assurance Engineer - Medical Device Manufacturing [Singapore]


 

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Role Overview:

  • Work Schedule: Monday to Friday, 8:30 a.m. to 6:00 p.m.
  • Location: Serangoon North
  • Monthly Salary Range: Up to $5500 (Base Salary)

Key Responsibilities:

  • Collaborate with various departments to ensure a thorough understanding and adherence to the Quality Management System.
  • Oversee and manage quality audits.
  • Establish and implement necessary procedures and processes.
  • Continuously review the Quality Management System for ongoing suitability and identify areas for improvement.
  • Conduct awareness training on ISO13485, ISO14971, and FDA 21 CFR Part 820, with provision for refresher training as needed.
  • Coordinate and plan external audits, such as Customer, ISO certification, and Regulatory bodies.
  • Supervise and mentor assigned individuals to ensure the timely and accurate completion of quality projects.
  • Support plant-wide audit/inspection activities and special projects.

Entry Requirements:

  • Bachelor's Degree in Quality Management or Electronics Engineering.
  • Minimum of 3 years of experience working with Quality Management Systems in a manufacturing environment.
  • Extensive practical knowledge of Quality Management Systems, particularly ISO 13485 and FDA 21 CFR Part 820.
  • Ability to establish control systems required in ISO13485 & FDA registered facilities.

If you meet the above qualifications and are interested in this exciting role, click " Apply Now " to submit your application.

Recruit Lync Pte Ltd | EA Licence Number: 22C1000

Poon Weng Teik (Wilson) | EA Personnel Licence: R1657737

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