Quality Assurance Leader – ISO 15189, Global Lab Network

ID Imagerie; Bern; On-site; CHF 120,000 - 160,000; Full time

Benefits offered by this job

40-hour work week

5 weeks vacation

Annual personal analyses allowance

Radiological advice discounts

Job summary

Unilabs is seeking a Quality Manager to lead the Quality programs, systems, and processes across the hospital laboratories network in Switzerland (Bern preferred). The role ensures compliance with ISO 15189:2022, IVDR, and related requirements, while coordinating audits and continuous improvement efforts.

The position involves regular collaboration with procurement, country leadership, and laboratory management to maintain licensure and accreditation across sites.

Qualifications

• Bachelor's or master's in a technical/QA field with lab experience.
• Prior ISO 15189 accredited lab experience preferred.
• Experience with medical device or IVDR regulation is a plus.
• 5–10 years of leadership/people management experience.

Responsibilities

• Maintain and improve the Quality Management System (QMS) in labs.
• Ensure licensure and accreditations are current across sites.
• Lead quality programs and drive regulatory compliance.
• Coordinate accreditation audits and respond to findings.
• Promote a culture of quality and educate staff on QMS tools.
• Monitor risk, perform root cause analysis, and drive CAPAs.

Skills

ISO 15189

Quality Management

Regulatory Compliance

Leadership

Multilingual (FR/DE/EN)

Education

Bachelor's or Master's in QA/Engineering

Tools

QMS Software

Job description

Unilabs is seeking a Quality Manager to lead the Quality programs, systems, and processes across the hospital laboratories network in Switzerland (Bern preferred). The role ensures compliance with ISO 15189:2022, IVDR, and related requirements, while coordinating audits and continuous improvement efforts.

The position involves regular collaboration with procurement, country leadership, and laboratory management to maintain licensure and accreditation across sites.