Job Description

• Industry/ Organization Type: Manufacturing
• Position Title: QA Engineer / Quality Assurance Engineer
• Working Location: Serangoon
• Working Hours: 5 days (Monday to Friday, 8.30 AM - 6 PM)
• Salary Package: Basic Salary up to $5,500 + OT + Variable Bonus
• Duration: Permanent

Key Responsibilities

• Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented
• Coordinate with various functions to ensure awareness and understanding of the Quality Management System.
• Plan and coordinate 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
• Coordinate 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/customers visits
• Any other ad-hoc duties as assigned

APPLY NOW!!!

• Bachelor\'s Degree in Quality Management or Electronics Engineering
• At least 3 years of working experience in Quality Management Systems, and in a manufacturing environment
• Excellent hands-on knowledge of Quality Management Systems 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

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