collana gmbh
Projektleiter Patientenadministration (m/w/x)
Vollzeit/Teilzeitmit HomeofficeSenior
Bern
UNUnilabs
Quality Assurance Manager Proximity and Hospital Laboratories (m/w/x)
VollzeitRemoteSenior
Nejo KI-Zusammenfassung
Overseeing quality programs for a Swiss diagnostics lab network, ensuring ISO 15189:2022 compliance. ISO 15189:2022 and IVDR knowledge required. International work environment, direct responsibility.
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Anforderungen
- Demonstrates and promotes company vision and policy
- Maintains current laboratory licensure and accreditations
- Manages Quality Management System (QMS) in compliance with ISO 15189:2022, IVDR, and company policies
- Provides assistance on quality related issues
- Promotes quality culture through education on QMS fundamentals, programs, and tools
- Prepares accreditation dossiers, accompanies auditors, and coordinates responses to audit findings
- Ensures identification and documentation of non-conformances, adverse events, and complaints
- Assesses risk, assists in root cause analysis and corrective actions, monitors trends, and creates reports
- Manages post-market incident activities (field safety corrective action, vigilance reporting)
- Ensures continuous improvement through indicators, dashboards, and corrective actions
- Prepares annual Quality Management Review meeting
- Monitors supplier compliance readiness with IVDR and ensures risk management procedure execution
- Represents Quality function in projects, M&A due diligence, and integration processes
- Facilitates crisis management for business continuity
- Performs other duties as assigned
- Bachelor’s or master’s degree in technical/process engineering/QA discipline with significant laboratory experience
- In-depth experience in ISO 15189 accredited diagnostic laboratory with QMS focus
- Experience with medical device regulation and/or in-vitro diagnostic directive regulation
- 3 years People Leadership Operations experience (preferred)
- Excellent interpersonal, organizational, and communication skills with attention to detail
- Self-motivated, driven critical thinker in high pace, rapidly changing environment
- Responsive problem solver and action oriented
- Ability to affect change and willingness to travel 25% of the time
- Ability to write reports, business correspondence, and procedure manuals
- Ability to effectively present information and respond to questions
- Ability to work independently, initiate contacts, and be a good team player
Aufgaben
- Manage quality programs, systems, processes, and procedures for the laboratory network, adhering to regulatory and accreditation requirements.
- Ensure the performance and quality of services for the laboratory network, adhering to regulatory and accreditation requirements.
Berufserfahrung
5 - 10 Jahre
Ausbildung
Master-Abschluss
Sprachen
Französisch – verhandlungssicher
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Italienisch – Grundkenntnisse
Tools & Technologien
ISO 15189:2022IVDR
Benefits
Lockere Unternehmenskultur
- International work environment
- Positive work climate
- Appreciative company culture
Sinnstiftende Arbeit
- Responsibility
Karriere- und Weiterentwicklung
- Potential development
Startup-Atmosphäre
- Collaborative partnership
Sonstige Vorteile
- Attractive fringe benefits
- Special prices for radiological consulting
Sonstige Zulagen
- Annual allowance for personal analyses
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Unilabs erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei UnilabsÜber das Unternehmen
UN
HealthcareBern
Unilabs is a leading diagnostics company in Switzerland, offering a comprehensive range of laboratory, pathology, and imaging services.
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