Quality Assurance Manager – Proximity and Hospital Laboratories

About the role

Unilabs, one of Europe's leading diagnostic companies, is looking for a Quality Assurance Manager for its proximity and hospital laboratories network in Switzerland. The role covers quality programmes, systems, processes and procedures, and the performance and quality of services in line with regulatory and accreditation requirements. The position is based in Bern (preferred), with possible locations in Dübendorf, Lausanne or Manno.

Key responsibilities

• Ensure laboratories maintain current licensure and accreditations, and manage, maintain and improve the Quality Management System (QMS) in line with ISO 15189:2022, IVDR and company policy.
• Prepare accreditation dossiers, accompany auditors during laboratory audits and coordinate responses to audit findings.
• Document non-conformances, adverse events and complaints, assess risks, support root cause analysis and corrective actions, and monitor trends for quality meetings and management reviews.
• Manage post-market incident activities (field safety corrective action, vigilance reporting) and run the annual Quality Management Review.
• Monitor supplier compliance with IVDR, implement the risk management procedure, and represent the Quality function in M&A due diligence and integration projects.
• Participate in crisis management and perform other duties as assigned.

Required profile

• Bachelor's or master's degree in a technical, process engineering or QA discipline, with significant laboratory experience.
• Prior in-depth experience in an ISO 15189 accredited diagnostic laboratory, ideally with medical device and IVDR regulation experience.
• 3 years of people leadership operations experience preferred; 5-10 years recommended.
• Fluent French, German and English; Italian a plus.
• Willingness to travel 25% of the time to stay in regular contact with laboratories.

Required skills

• Excellent interpersonal, organisational and communication skills, with attention to detail.
• Ability to write reports, business correspondence and procedure manuals, and to present information clearly.
• Ability to work independently and in a fast-paced, changing environment.

What we offer

• An international, dynamic work environment with opportunities to take responsibility.
• A 40-hour week and 5 weeks of holiday per year.
• Annual personal test allowance and special rates for radiology acts within the Unilabs group.