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QA Engineer #65191

3 weeks ago

Serangoon, Singapore Anradus Pte Ltd Full time

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

Anradus Pte Ltd | EA License No. 20C016 | Angel Lim | EA Reg No: R1769781

Pay: $3,200.00 - $5,500.00 per month

Schedule:

- Late shift

License/Certification:
Work Location: In person