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/PQ validation protocols and reports, ensuring all equipment and process revalidations meet compliance benchmarks.
- Manage the lifecycle of all controlled documentation (SOPs, WIs, Technical Files) and partner with HR to deliver QMS and regulatory compliance training across teams.
about the experience
... 
