QMS Engineer [Medical Device]

Our client is a powerhouse global leader in medical device manufacturing, dominating the healthcare innovation space. Driven by a relentless obsession with regulatory perfection, they offer a high‑velocity environment where you don't just follow standards - you set them.

If you are a QMS expert hungry for elite industry exposure and a fast‑tracked path to leadership, this is your next definitive career move.

About the Job

• Establish, maintain, and continuously improve the QMS in strict accordance with ISO 13485, ISO 14971, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements.
• Plan and execute internal audits while serving as the primary host and coordinator for customer, certification, and regulatory (MDSAP/FDA) external inspections.
• Drive ISO 14971 risk‑management activities (DFMEA/PFMEA, Control Plans) and evaluate quality/regulatory impacts within the Change Control Board (CCB).
• Participate in and approve IQ/OQ/P...

Ready to Apply?

Submit your application today and join our talented team at Randstad Malaysia.