Quality Assurance Manager Proximity and Hospital Laboratories - Schweiz in Bern

Introduction

Unilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people.

Your Tasks

The Quality Manager is responsible for the Quality programs, systems, processes and procedures and for the performance and quality of services in compliance with established regulatory and accreditation requirements within the proximity and hospital laboratories network.

100% - Bern (preferred), Dübendorf, Lausanne, Manno (possible)

Your Profile

Key Responsibilities

• Demonstrates and promotes the company vision and policy.
• Ensure the laboratories maintain current licensure and accreditations, as applicable.
• Manages, maintains, and improves the Quality Management System (QMS) of the laboratories in compliance with industry standards (ISO 15189:2022), regulatory requirements such as IVDR, and company policies.
• Provides assistance where indicated on quality related issues.
• Promotes a culture of quality by educating others in quality management system fundamentals, programs and tools. Communicates significant changes that could impact the scope or capability of the laboratories to accreditation organizations.
• Participates in the preparation of accreditation dossiers, accompany auditors (e.g. ISO quality inspectors) during audits of the laboratories and coordinates responses to audit findings.
• Ensures non-conformances, adverse events and complaints are identified and documented and that timeliness requirements are met.
• Assesses risk, assists in root cause analysis and corrective action efforts. Monitors trends and create reports for periodic quality meeting and management review.
• Manages post-market incident activities (field safety corrective action, vigilance reporting).
• Ensures continuous improvement: indicators and dashboards, implementation and monitoring of preventive and corrective actions.
• Prepares Quality Management Review meeting at least once per year in cooperation with quality team, laboratory management and Country Leadership Team.
• Monitors in collaboration with procurement team the compliance readiness of suppliers of commercial CE-IVD devices with IVDR. Ensures appropriate implementation and execution of the risk management procedure.
• Represents Quality function in projects, due diligence assessment done as part of the M&A Process and in the integration process for newly acquired companies.
• Facilitates or participates, as applicable, in crisis management with relevant channels to ensure business continuity.
• Performs other duties as assigned.

Education And Experience

Bachelor’s degree or master’s degree in a technical/ process engineering/QA discipline, with significant related professional experience within the laboratory environment.

Prior in-depth experience working in an ISO 15189 accredited diagnostic laboratory with a focus on Quality Management Systems.

Ideally experience with medical device regulation and/or in-vitro diagnostic directive regulation.

3 years of People Leadership Operations experience, preferred. Fluent / speaks professionally French, German and English. Italian a plus Minimum Years Recommended and/or Preferred: 5-10 years

Required Skills

• Excellent interpersonal, organizational & communication skills with excellent attention to detail.
• Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
• Responsive problem solver and action oriented.
• Ability to affect change. Willingness to travel 25% of the time to have regular contacts in the laboratories
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions.
• Ability to work independently and initiate contacts as necessary. Good team player.

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