Quality Assurance Lead — ISO 15189, Global Lab Network

Jobup; Bern; On-site; CHF 120,000 - 180,000; Full time

Benefits offered by this job

International environment

40-hour week

5 weeks vacation

Fringe benefits

Job summary

Unilabs is seeking a Quality Manager to oversee quality programs, systems and procedures, ensuring service performance aligns with regulatory and accreditation requirements within the hospital laboratories network. The role covers Bern and nearby labs such as Dübendorf, Lausanne, and Manno.

You will drive a culture of quality, lead audits, manage risk, and coordinate with procurement and Country Leadership Team to ensure continuous improvement and timely responses to audit findings.

Qualifications

• Bachelor's or master's degree in a technical/process engineering/QA discipline with significant experience in laboratory environments.
• In-depth experience in an ISO 15189 accredited diagnostic laboratory focusing on Quality Management Systems.
• Ideally experience with medical device regulation and/or IVDR regulation.
• 3 years of people leadership/operations experience is preferred.

Responsibilities

• Promotes the company vision and policy.
• Ensures laboratories maintain current licensure and accreditation.
• Manages the Quality Management System (QMS) in compliance with ISO 15189:2022, IVDR and policies.
• Assists with quality issues and educates others in QMS fundamentals and tools.
• Communicates changes impacting accreditation to relevant bodies.

Skills

QMS

ISO 15189

Auditing

Regulatory

Multilingual

Leadership

Travel readiness

Report writing

Education

Bachelor's or Master's in technical/QA

Job description

Unilabs is seeking a Quality Manager to oversee quality programs, systems and procedures, ensuring service performance aligns with regulatory and accreditation requirements within the hospital laboratories network. The role covers Bern and nearby labs such as Dübendorf, Lausanne, and Manno.

You will drive a culture of quality, lead audits, manage risk, and coordinate with procurement and Country Leadership Team to ensure continuous improvement and timely responses to audit findings.