Quality Systems Lead – Medical Devices

A leading medical device consulting company is looking for a **Quality Systems Lead** to join its professional team.

This is an exciting opportunity to lead quality systems and processes, provide consulting and guidance to medical device companies, and work with clients operating in complex regulatory environments.

**Key Responsibilities:**
• Support, maintain, and improve QMS in compliance with ISO 13485, EU MDR, IVDR, QMSR, and ISO 27001.
• Lead CAPA, NC, Complaints, Deviations, and Change Control processes.
• Manage Document Control, including DHF / DMR / DHR.
• Lead Management Reviews, CRB, and ISO 13485 / MDR / IVDR audits.
• Manage supplier quality activities, including ASL, SCAR, and QAA.
• Support product release, QC testing, calibration, and operational controls.
• Work closely with clients and cross-functional teams, including R&D, Manufacturing, Operations, Procurement, and Quality.
• Lead quality initiatives, implement regulatory requirements, and manage multiple projects simultaneously.
• Provide tailored quality solutions based on client needs.
דרישות התפקיד
Technical or scientific degree.
5+ years of quality management experience in the medical device industry.
Hands-on experience with EU Class IIb / Class III medical devices.
Proven experience with ISO 13485, EU MDR, and IVDR, including audit leadership.
Practical experience with QMS, CAPA, NC, Deviations, Change Control, and Document Control.
Ability to combine a systemic perspective and professional leadership with hands-on execution.
Experience working with clients and managing multiple projects simultaneously.
Excellent English communication skills.
Experience with Gamma / EtO sterilization processes – a significant advantage.