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Quality engineer investigations

Lausanne
Michael Page International (Switzerland) SA
Ingenieur Qualitätssicherung
EUR 100’000 - EUR 125’000 pro Jahr
Inserat online seit: 19 Mai
Beschreibung

Direct impact on product quality and regulatory complianceDynamic international environment within a highly regulated industryAbout Our ClientOur client is an international company operating in a highly regulated environment. It offers a dynamic workplace focused on innovation, quality, and operational excellence.Job DescriptionLead and coordinate the CAPA (Corrective and Preventive Actions) systemConduct thorough investigations and root cause analysesManage non-conformance processes (NCMR) end-to-endFacilitate CAPA review boards and collaborate with internal and external stakeholdersDefine, implement, and monitor corrective and preventive action plansTrack quality metrics and identify improvement opportunitiesApply problem-solving methodologies (Ishikawa, DMAIC, Lean tools)Drive continuous improvement initiatives across quality processesSupport supplier investigations and monitor supplier performanceContribute to internal and external audits (preparation, execution, follow-up)Ensure compliance with international regulations (ISO, FDA, MDR, etc.)The Successful ApplicantScientific degree (engineering, life sciences, pharmacy, or equivalent)3-5 years of experience in Quality Assurance within a regulated environmentExperience in medical devices or pharmaceutical industryStrong knowledge of ISO 13485, FDA, MDD/MDR regulationsExpertise in CAPA, non-conformance management, and investigationsProficiency in root cause analysis tools and Lean methodologies Strong project management and prioritization skillsGood command of quality systems and IT tools (MS Office, QMS software)Excellent communication and cross-functional collaboration skillsFluent in French and good level of EnglishAnalytical mindset, attention to detail, and high integrityWhat's on OfferInternational and high-impact working environmentStrategic role with strong visibility within a temporary assignmentOpportunities for professional development and growth within a defined mission
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