Quality Assurance Specialist

About the role

Surgitec Robotics is seeking a Quality Assurance Specialist to lead the quality management system for its AI‑assisted surgical robotics platform, Surge One®. The role bridges regulatory compliance and product development, ensuring that quality is embedded from design through market launch.

Key responsibilities

• Own and continuously improve the Quality Management System (QMS) in line with ISO 13485, MDR, and FDA 21 CFR Part 820.
• Lead internal audits, conduct supplier audits, and act as the primary contact for notified bodies.
• Integrate design controls and regulatory requirements into R&D, hardware, software, and clinical affairs activities.
• Participate in FMECA workshops, risk analyses, and design reviews, applying ISO 14971 risk‑management principles.
• Manage non‑conformities, complaints, and drive CAPA initiatives.
• Qualify suppliers, negotiate quality agreements, and oversee supplier corrective actions.

Required profile

• Master’s degree in Quality, Biomedical Engineering, Life Sciences, Mechatronics, Pharmacology or related field.
• 5–7 years of quality experience on complex medical devices, including hardware, software, and AI components.
• Proven experience with Class IIb/III medical devices (active, implantable, or robotic).
• Certification in quality management (e.g., ISO 13485 Lead Auditor, ASQ CQE, RAPS RAC) is a strong asset.

Required skills

• ISO 13485
• ISO 14971
• EU Medical Device Regulation (MDR)
• FDA 21 CFR Part 820
• Risk analysis and FMECA
• CAPA management
• Internal and supplier audit execution
• Quality Management System (QMS) administration