Quality Assurance Leader – Medical Lab Diagnostics

Unilabs Switzerland; Bern; On-site; CHF 110,000 - 180,000; Full time

Job summary

Unilabs Switzerland is seeking a Quality Manager to oversee the Quality programs, systems, and procedures across its hospital laboratory network in Switzerland. You will ensure compliance with ISO 15189:2022 and IVDR, maintain licensure and accreditations, and drive continuous improvement through indicators, dashboards, and corrective actions.

The role involves collaboration with procurement and country leadership, participation in audits, and travel up to 25% to labs including Bern, Dübendorf,

Qualifications

• Bachelor’s or master’s degree in a technical/process engineering/QA discipline.
• Experience in an ISO 15189 accredited diagnostic laboratory.
• Ideally experience with medical device regulation and/or IVDR.
• 3 years of People Leadership Operations experience, preferred.

Responsibilities

• Promotes the company vision and policy.
• Ensures licenses and accreditations are current for the laboratories.
• Maintains and improves the Quality Management System (QMS) per ISO 15189:2022 and IVDR.
• Assists with quality issues and facilitates adherence to quality programs.
• Educates staff on quality management systems and conducts audits.

Skills

People leadership

Quality management

Regulatory compliance

Report writing

Communication

Travel readiness

Independent work

Team collaboration

Multilingual (FR, DE, EN)

Education

Bachelor’s or Master’s in QA/Engineering

Job description

Unilabs Switzerland is seeking a Quality Manager to oversee the Quality programs, systems, and procedures across its hospital laboratory network in Switzerland. You will ensure compliance with ISO 15189:2022 and IVDR, maintain licensure and accreditations, and drive continuous improvement through indicators, dashboards, and corrective actions.

The role involves collaboration with procurement and country leadership, participation in audits, and travel up to 25% to labs including Bern, Dübendorf,