Lead QA

Winterthur, Switzerland

Full-Time | Senior / Lead Level

About the Role

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.

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
• 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 , 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
• 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.