QA Engineer

2 weeks ago

Serangoon, Singapore Search Personnel Pte Ltd Full time

**Position : QA Engineer**:

- **Location : Serangoon**:

- **Working hours : 5 Days - Mondays to Fridays | 8:30am to 6pm**:

- **Salary (commensurate with experience): Up to $6,000 + Medical Coverage + Variable Bonus + 14 days Annual Leave**:

- **Duration : Permanent**:

- **Industry : Telecomm Manufacturer**

**Responsibilities**:

- 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

**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
- Bilingual in both English and Mandarin to liaise with Mandarin speaking associates in view of business communications.

Angela Ng

Executive Consultant

Reg no.: R23112075 | EA No: 13C6684

**Salary**: $3,200.00 - $6,000.00 per month

Schedule:

- Day shift
- Monday to Friday

Work Location: One location

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