Lead QA (Quality Assurance) – QMS & Certification for Medical Robotic Systems
We are seeking an experienced and highly structured Lead QA professional to drive certification activities and lead the development, implementation, and continuous improvement of our Quality Management System (ISO 13485 / MDR / FDA).
In this role, you will ensure compliance for Class II/III medical devices, including surgical robotic systems and complex mechatronic products. You will work closely with R&D (mechanical, electronics, software), RA, clinical, production, and suppliers to ensure quality and safety are embedded throughout the product lifecycle.
Key Responsibilities
* Develop, implement, and continuously improve the Quality Management System in accordance with ISO 13485, EU MDR, and FDA 21 CFR 820.
* Lead and manage internal, supplier, and external audits, including Notified Body and FDA inspections.
* Create, update, and manage SOPs, work instructions, templates, and quality processes.
* Ensure full compliance with Design Controls throughout the development lifecycle.
* Lead QA activities for preparation and maintenance of technical documentation for robotic medical devices.
* Collaborate with Regulatory Affairs on CE marking, FDA submissions (De Novo, 510(k), PMA), and global registrations.
* Provide QA oversight for mechanical, electronics, mechatronics, and embedded software engineering teams.
* Review and approve Verification & Validation protocols and reports (DVP&R), design documentation, and software lifecycle documentation.
* Lead risk management activities (hazard analysis, FMEA, Fault Tree Analysis) and ensure risk controls are implemented and maintained.
* Manage supplier qualification, audits, and incoming quality controls; support design transfer to manufacturing.
* Lead post‑market quality processes (PMS, PMCF, CAPA, NC handling, complaint management).
* Mentor QA engineers and guide cross‑functional teams; lead initiatives to enhance the quality culture.
Qualifications
Required
* Degree in Biomedical Engineering, Mechanical/Electrical Engineering, Mechatronics, Quality Engineering, or related field.
* 7+ years of QA experience with Class II/III medical devices; strong preference for robotic systems or complex mechatronic devices.
* In‑depth knowledge of ISO 13485, ISO 14971, EU MDR (Annex II & III), FDA 21 CFR 820, IEC 60601‑1, IEC 62304, IEC 62366, ISO 10993.
* Demonstrated experience building or scaling a QMS.
* Hands‑on experience with Notified Body or FDA audits.
* Strong cross‑functional communication and documentation skills.
* Fluency in English required; German is a strong plus.
Preferred
* Lead Auditor certification (ISO 13485 and/or ISO 14971).
* Experience with surgical robotics, software‑intensive medical systems, electromechanical product development.
* Previous leadership of QA teams or quality streams.
About the Role
Location: Winterthur, Switzerland (Full‑time, Senior / Lead Level)
Why Join Us?
* Work with cutting‑edge medical robotic technologies.
* Shape the future of our QMS and influence product certification strategy.
* High ownership and impact in a rapidly growing MedTech environment.
* A culture where engineering excellence, patient safety, and innovation come first.
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