QA Associate (1 year/MEDICAL DEVICE MNC) - up to $4200/West #HAO
Summary
QA Associate for a medical device multinational, ensuring compliance with global regulations by compiling quality metrics, supporting audits, and maintaining QMS documentation.
Salary: up to $4200
Duration: 1 year
Working Days & Hours: Mon-Fri Office Hours
Location: Tuas (CCK, Jurong East, woodlands, Outram pickup)
Job Description:
- Compile and analyze quality metrics, and support Management Review reporting
- Coordinate and prepare Annual Product Quality Review (APQR) reports
- Support document control, QMS maintenance and artwork review processes
- Support inspection readiness activities, including preparation for internal audits and regulatory inspections (e.g., Health Authorities, Notified Bodies)
- Coordinate and track responses to inspection observations, ensuring timely closure
- Review and approve change controls, ensuring compliance with regulatory expectations
- Support Data Integrity initiatives and promote compliance with principles
- Ensure adherence to GMP, ISO 13485, MDSAP, EU MDR, and local regulatory requirements (e.g., HSA)
- Identify opportunities for continuous improvement in quality systems
Job Requirements: Min Diploma/Degree in Life Sciences or similar & min relevant 2 yrs of experience &Knowledge of GMP and ISO 13485 quality systems, Regulatory frameworks (e.g., HSA, EU MDR, MDSAP) and Data integrity principle
Interested candidates, please submit your resume to: allylok@recruitexpress.com.sg
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
allylok@recruitexpress.com.sg