- 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.
- 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.
- 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.
Job Requirements:
- Degree with 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.
Interested applicants, please email us your resume to [email protected]
E-Ployment Consultancy
EA License No: 09C0884
EAP Name/ Registered No: Ivan Mah/ R1108310
