pUnilabs is the largest provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland and employs around 800 people. /p h3Your Tasks /h3 pTheQuality Manageris 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. /p h3Your Profile /h3 pbKey responsibilities /b /p pDemonstrates and promotes the company vision and policy. /p pEnsure the laboratories maintain current licensure and accreditations, as applicable. /p pManages, 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. /p pProvides assistance where indicated on quality related issues. /p pPromotes 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. /p pParticipates in the preparation of accreditation dossiers, accompany auditors (e.g. ISO quality inspectors) during audits of the laboratories and coordinates responses to audit findings. /p pEnsures non-conformances, adverse events and complaints be identified and documented and that timeliness requirements are met. /p pAssesses risk, assists in root cause analysis and corrective action efforts. Monitors trends and create reports for periodic quality meeting and management review. /p pManages post-market incident activities (field safety corrective action, vigilance reporting). /p pEnsures continuous improvement: indicators and dashboards, implementation and monitoring of preventive and corrective actions. /p pPrepares Quality Management Review meeting at least once per year in cooperation with quality team, laboratory management and Country Leadership Team. /p pMonitors 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. /p pRepresents Quality function in projects, due diligence assessment done as part of the MA Process and in the integration process for newly acquired companies. /p pFacilitates or participates, as applicable, in crisis management with relevant channels to ensure business continuity. /p pPerforms other duties as assigned. /p pbEducation and Experience /b /p pBachelor’s degree or master’s degree in a technical/ process engineering/QA discipline, with significant related professional experience within the laboratory environment. /p pPrior in-depth experience working in an ISO 15189 accredited diagnostic laboratory with a focus on Quality Management Systems. /p pIdeally experience with medical device regulation and/or in-vitro diagnostic directive regulation. /p p3 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 /p pbRequired skills /b /p pExcellent interpersonal, organizational communication skills with excellent attention to detail. /p pSelf-motivated and driven critical thinker able to work in high pace and rapidly changing environment. /p pResponsive problem solver and action oriented. /p pAbility to affect change. Willingness to travel 25% of the time to have regular contacts in the laboratories /p pAbility to write reports, business correspondence, and procedure manuals. /p pAbility to effectively present information and respond to questions. /p pAbility to work independently and initiate contacts as necessary. Good team player. /p h3We Offer /h3 ul liAn exciting and dynamic work environment with a lot of internationality /li liTaking responsibility and unfolding your potential /li liA positive working atmosphere with a partnership and appreciative corporate culture /li liAttractive fringe benefits as well as a 40-hour week and 5-weeks vacation /li liAnnual fee for your personal analyses and special prices for radiological advice from the Unilabs Group /li /ul #J-18808-Ljbffr
Quality Assurance Manager Proximity and Hospital Laboratories - Schweiz Arbeitgeber: Unilabs Group Services
Unilabs Group Services Lausanne ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, in einem modernen technischen Umfeld zu arbeiten und sich kontinuierlich weiterzuentwickeln. Die Unternehmenskultur fördert Teamarbeit und Qualität in der Patientenversorgung, während flexible Arbeitszeiten und umfassende Schulungsprogramme sicherstellen, dass jeder Mitarbeiter sein volles Potenzial entfalten kann. Zudem profitieren Sie von einer attraktiven Lage in Lausanne, die sowohl berufliche als auch persönliche Lebensqualität vereint.
