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 that quality and safety are embedded throughout the product lifecycle.
This position is ideal for a proactive leader with deep expertise in QMS, regulatory compliance, and quality engineering for advanced medical technologies.
📍 Winterthur, Switzerland
🕒 Full-Time | Senior / Lead Level
Key Responsibilities
1. QMS Leadership & Compliance
* 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.
2. Certification & Regulatory Compliance Support
* Lead QA activities for preparation and maintenance of Technical Documentation / Technical File / Design Dossier for robotic medical devices.
* Collaborate with Regulatory Affairs on CE marking, FDA submissions (De Novo, 510(k), PMA), and global registrations.
* Ensure adherence to international standards, including:
* IEC 60601-1
* IEC 62304
* ISO 14971
* IEC 61010
* ISO 10993
* IEC 62366
3. Design Assurance & Engineering Collaboration
* Provide QA oversight for mechanical, electronics, mechatronics, and embedded software engineering teams.
* Review and approve:
* Verification & Validation protocols and reports (DVP&R)
* Mechanical/electrical design documentation
* Software lifecycle documentation (IEC 62304)
* Ensure full traceability from requirements → risk controls → V&V evidence.
4. Risk Management (ISO 14971)
* Lead and facilitate all risk management activities, including:
* Hazard analysis
* dfMEA / pfMEA
* Fault Tree Analysis
* Ensure risk controls are effectively implemented and maintained throughout development and post-market phases.
5. Supplier & Production Quality
* Manage supplier qualification, audits, and incoming quality controls.
* Support design transfer to manufacturing and ensure production processes meet quality requirements for complex robotic systems.
* Drive continuous improvement in production quality metrics.
6. Post-Market Quality Processes
* Lead PMS, PMCF, CAPA, NC handling, and complaint management.
* Analyze product reliability and safety data for preventive improvements.
7. Leadership & Mentorship
* Mentor QA engineers and guide cross‑functional teams in quality‑related topics.
* Lead initiatives to enhance the quality culture across R&D and Operations.
Your 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 experience with 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 NB 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.
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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