Senior QA/RA Project Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dyt2y

EMS is a global leader in the design, manufacturing, and sale of devices used for medical and dental treatments. With over 40 years of expertise, EMS embodies Swiss precision and craftsmanship, delivering innovative solutions in:
- Urology
- Shock Wave Therapy

At EMS, we are driven by our core values: Respect, Excellence,and Client Orientation. Our mission is simple: to ensure happy and healthy patients, successful clinicians, and passionate partners through the least invasive and clinically proven treatments.
MISSION
As the primary Quality and Regulatory Affairs representative for the Pain Therapy Business Unit, you will provide strategic and operational QA/RA leadership across the full product lifecycle — from concept and development through market access, post-market activities and lifecycle management — in close collaboration with R&D;, Product Management, Manufacturing and Supply Chain.
RESPONSIBILITIES
- Act as the single QA/RA point of contact and lead for the Pain Therapy Business Unit, covering all related development, sustaining and lifecycle projects.
- Define,



maintain and execute the QA/RA strategy for the Business Unit, aligned with business priorities, product roadmaps and applicable regulatory requirements.
- Provide functional QA/RA leadership to cross-functional project teams (R&D;, Product Management, Manufacturing, Supply Chain), without direct hierarchical authority.
- Ensure clear ownership, planning, prioritisation and timely completion of all QA/RA deliverables.

Product Development and Design Control
- Lead and coordinate QA/RA activities throughout product development, ensuring appropriate QA/RA input into Design Control activities owned by R&D.;
- Review and approve relevant Design Control deliverables, and support design reviews, verification & validation strategies, usability, software and electrical safety activities.
- Coordinate cybersecurity requirements, risk assessments and documentation for connected medical devices.
- Lead QA/RA ac

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dyt2y