QA Specialist (Medical Device MNC)
Recruit Express Pte Ltd| Date Posted: 16-Aug-2019
EA Licence No: 99C4599|EA Personal Registration No: R1763413
Diploma, Bachelor's / Honours, Masters / PhD
- Implementation and Maintenance of the Document Management System
- Ensures that the Quality Management System is maintained including supporting the site’s periodic Management Review Meeting.
- Facilitates the periodic Internal Quality Audit Program and conducts audits as per ISO 13485, 21 CFR Part 11, and or MDR requirements and or applicable local regulatory standards.
- Liaise with Certification/Notified bodies in arranging Surveillance or Recertification Audits. Participate and support the local site during these audits and follow-up the closure of audit findings with NC owners.
- Administration of QMS Trainings in Learning Management tool(s).
- Submission of periodic reports such as Quality Metrics and Supplier performance reports.
- Supports the Post Market Surveillance (PMS) activities, Complaints handling, Quality Hold & Field Action implementations in coordination with S&N stakeholders such as but not limited to Supply Chain, Sales team, and Global Complaints team.
- Adhere to Company and Industry regulation and policies.
- Assist, follow-up, review and or approval of Rootcause Investigations and CAPA for Product Complaints.
- Min Degree with 3 year of experience
- QA Experience in a Healthcare or Medical Device company will be an advantage
- Preferred ISO 13485 or ISO 9001 Certified Internal or Lead Auditor
For enquiries, you can contact Alex Goh Hock Leong - R1763413
**All information will be treated with the strictest confidence. We regret that only short-listed applicants will be notified.
Recruit Express Pte Ltd