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QA Engineer #53465

3 weeks ago

Serangoon, Singapore Anradus Pte Ltd Full time

Industry/ Organization Type: Manufacturing/ Production
- Position Title**:QA Engineer/ Quality Engineer**:

- Working Location: Serangoon North
- Working Hours: Monday to Friday, 8.30 am - 6 pm
- Salary Package**:Up to $5,000 + 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 co-ordinate gap analysis exercises and provide advice on bridging the gap
- Manage and oversee quality audits by plan and ensuring 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 the 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 audits such as Customer, ISO certification and Regulatory bodies
- Support Plant wide audit/ inspection activities and special projects, as assigned

**APPLY NOW**
- At least Degree in Quality Management, Engineering or its equivalent
- Minimum 3 years of working experience in Quality Management Systems, and in the manufacturing environment
- Excellent hands-on knowledge of Quality Management System primarily in ISO 13485 and FDA 21 CFR Part 820
- Establish controls system required in ISO13485 & FDA registered facility
- FDA Inspection experience preferred
- Able to travel for suppliers/customer visits

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

**Job Types**: Full-time, Permanent

**Salary**: $3,000.00 - $5,000.00 per month

License/Certification:
Work Location: One location