Quality Assurance Manager – Proximity and Hospital Laboratories

About the role

Unilabs, the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland, is looking for a Quality Manager for its proximity and hospital laboratories network. The manager is responsible for the quality programmes, systems, processes and procedures, and for the performance and quality of services, in line with regulatory and accreditation requirements. The role is based in Bern (preferred), with Dübendorf, Lausanne or Manno also possible.

Key responsibilities

• Promote the company vision and policy and ensure laboratories keep their current licensure and accreditations.
• Manage, maintain and improve the Quality Management System (QMS) in line with ISO 15189:2022, IVDR and company policies.
• Assist colleagues on quality issues, educate them on QMS fundamentals and tools, and communicate changes affecting accreditation scope.
• Take part in preparing accreditation dossiers, accompany ISO quality inspectors during audits and coordinate responses to audit findings.
• Ensure non-conformances, adverse events and complaints are identified, documented and handled on time; assess risks, support root cause analysis and corrective actions, and monitor trends for quality meetings and management reviews.
• Manage post-market incidents (field safety corrective action, vigilance reporting) and drive continuous improvement through indicators, dashboards and preventive/corrective actions.
• Prepare the annual Quality Management Review with the quality team, laboratory management and Country Leadership Team.
• Monitor supplier compliance with IVDR together with procurement, implement the risk management procedure, and represent Quality in M&A due diligence and integration.
• Participate in crisis management and perform other assigned duties.

Required profile

• Bachelor's or master's degree in a technical, process engineering or QA discipline, with significant laboratory experience.
• In-depth prior experience in an ISO 15189 accredited diagnostic laboratory focused on QMS.
• Ideally experience with medical device regulation and/or IVDR.
• Preferred: 3 years of people leadership operations experience and 5-10 years overall.
• Fluent French, German and English; Italian a plus.
• Willingness to travel 25% of the time.

Required skills

• Writing reports, business correspondence and procedure manuals.
• Presenting information and answering questions.
• Working independently and in teams, with strong organisational and communication skills.