Job Description

* Industry/ Organization Type: Manufacturing/ Production * Position Title: QA Engineer/ Quality Engineer * Working Location: Serangoon North * Working Hours: Monday to Frid 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 Kindly apply through ANY of the following methods: Submit your application by clicking the APPLY button Email your resume to . Please indicate #53465 on the email subject. Anradus Policy: This clarifies Anradus' working procedures, from receiving the applicant's resume, screening to shortlisting. We assure you our consultants will go through every resume we receive but we regret that only shortlisted candidates will be notified. Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641