Quality Assurance Manager Proximity and Hospital Laboratories - Schweiz
Core
Ensuring quality programs, systems, processes, and service performance across a network of proximity and hospital laboratories in compliance with regulatory and accreditation requirements.
Role type
Senior Quality Assurance Manager (Medical Laboratories)
Builds
Quality management systems (QMS) and compliance frameworks for diagnostic labs
Domain
Medical diagnostics / In-vitro diagnostics (IVD) / Healthcare
Required skills
ISO 15189:2022 compliance, IVDR regulation knowledge, risk management, audit coordination, non-conformance management, corrective and preventive actions (CAPA), supplier compliance monitoring, crisis management, M&A integration support
Preferred skills
Medical device regulation experience, leadership in operational QA, multilingual communication (French, German, English, Italian)
Technologies
ISO 15189, IVDR, QMS software tools
Responsibilities
Maintain lab licenses and accreditations, manage and improve the QMS, support quality-related inquiries, train staff on QA fundamentals, prepare accreditation dossiers and accompany auditors, document and resolve non-conformities and complaints, evaluate risks and support root cause analysis, monitor trends and report to management reviews, lead post-market surveillance activities, ensure supplier compliance for CE-IVD devices, represent QA in M&A due diligence, participate in crisis management for business continuity
Seniority
Senior, hands-on IC with leadership responsibilities