QA Specialist (Medical Device MNC)

Recruit Express Pte Ltd| Date Posted: 16-Aug-2019
EA Licence No: 99C4599|EA Personal Registration No: R1763413
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Job Nature:
Permanent
Position Level:
Experienced, Manager
Qualification:
Diploma, Bachelor's / Honours, Masters / PhD

Job Description

Responsibilities:

  • 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.

Requirement

  • 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

Email: [Click Here to Email Your Resume]

Contact: 67363280

**All information will be treated with the strictest confidence. We regret that only short-listed applicants will be notified.

 

Company Overview
Recruit Express Pte Ltd