Description:
- Basic up to $5500
- Variable Bonus + Good Benefits
- Monday to Friday
- 8.30AM-6PM
- Location: Serangoon
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
Additional Information:
- Bachelor’s Degree in Quality Management or Electronics/Mechatronics 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
Applicants who possess relevant experience for the above responsibilities are most welcome to apply. If you do not possess the above experience, your application will still be considered on individual merits and you may be contacted for other opportunities.
By submitting your personal data and/or resume, you give consent to collection, use and disclosure of your personal data and/or resume by the company (or its agent) for the purpose of the processing and administration by the company relating to this job application.
**We regret to inform that only shortlisted candidates would be notified.
R1873498
23C1910
