Über uns

Unilabs ist eines der führenden Diagnostikunternehmen in der Schweiz und bietet Patientinnen und Patienten ein umfassendes Angebot an Labor-, Pathologie- sowie Bildgebungsdienstleistungen. Als führender digitaler Champion, der das gesamte diagnostische Spektrum abdeckt, retten die weltweit mehr als 13’000 Mitarbeiter von Unilabs jeden Tag Leben. In der Schweiz zählen wir 1’000 Mitarbeitende.

Ihre Aufgaben

Promote and embody the company vision and policies while maintaining the genetic laboratory’s licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance with ISO 15189, ISO 17025, IVDR, and company standards, assisting with quality-related issues and fostering a culture of quality through education.

Communicate significant changes affecting laboratory capabilities to accreditation bodies, and prepare accreditation dossiers while accompanying auditors and coordinating responses to findings. Identify and document non-conformances, assess risks, and conduct root cause analyses, reporting trends at quality meetings.

Oversee post-market incident activities, drive continuous improvement through monitoring indicators and corrective actions, and organize annual Quality Management Review meetings with relevant teams. Ensure compliance of in-house devices with IVDR requirements, collaborate with procurement on supplier compliance, and implement risk management procedures.

Represent the Quality and Regulatory functions during M&A due diligence and integration processes, and participate in crisis management to ensure business continuity while performing other assigned duties as needed.

Was Sie mitbringen

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 in French and English, German is a plus
• Minimum Years Recommended and/or Preferred: 8-10 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.
• Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions.

Was wir Ihnen bieten

• Ein spannendes und dynamisches Arbeitsumfeld mit viel Internationalität
• Übernahme von Verantwortung und die Entfaltung deines Potentials
• Ein positives Arbeitsklima mit einer partnerschaftlichen Zusammenarbeit und einer wertschätzenden und anerkennenden Firmenkultur
• Attraktive Fringe Benefits sowie eine 40h Woche und 5 Wochen Ferien
• Jahrespauschale für Ihre persönlichen Analysen und Spezialpreise für radiologische Beratung bei der Unilabs-Gruppe

Kontakt

Herr Antonio Gambin, , freut sich auf Ihre Bewerbung.