Quality Assurance Manager - ISO 15189 & IVDR

Unilabs Group Services; Bern; Hybrid; CHF 110,000 - 140,000; Full time

Benefits offered by this job

International environment

Responsibility and growth

Positive working atmosphere

40-hour week

5 weeks vacation

Radiological advice discounts

Job summary

Unilabs Group Services in Bern, Switzerland, seeks a Quality Manager to lead the quality programs and ensure compliant services across the hospital laboratories network, aligned with ISO 15189:2022 and IVDR requirements.

You will manage the Quality Management System, drive continuous improvement, prepare accreditation dossiers, lead audits, and ensure timely handling of non-conformances and vigilance activities, while supporting risk assessment and management reviews.

Qualifications

• Excellent interpersonal, organizational & communication skills.
• Ability to lead quality initiatives in a high pace medical lab environment.
• Experience with ISO 15189 and IVDR regulatory requirements.

Responsibilities

• Lead quality programs and manage the QMS across hospital laboratories.
• Ensure licensure and accreditation are maintained and updated.
• Coordinate audits and accompany inspectors during assessments.
• Drive continuous improvement with dashboards and metrics.
• Oversee non-conformances, CAPAs, and incident investigations.
• Collaborate on risk management, supplier qualification, and training.

Skills

Leadership

Quality management

Communication

Problem solving

Analytical thinking

Team collaboration

Travel readiness

Education

Bachelor's or Master's in technical/process engineering/QA

ISO 15189 experience

Multilingual: French, German, English

Job description

Unilabs Group Services in Bern, Switzerland, seeks a Quality Manager to lead the quality programs and ensure compliant services across the hospital laboratories network, aligned with ISO 15189:2022 and IVDR requirements.

You will manage the Quality Management System, drive continuous improvement, prepare accreditation dossiers, lead audits, and ensure timely handling of non-conformances and vigilance activities, while supporting risk assessment and management reviews.