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 Job(at)anradus.com.sg. 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.: R1875641Job Types: Full-time, PermanentSalary: $3,000.00 - $5,000.00 per monthLicense/Certification:
identity to work without a sponsor(if no,we need apply pass) (Preferred)
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