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Quality engineer investigations

Lausanne
Michael Page Switzerland
Ingenieur Qualitätssicherung
Inserat online seit: 19 Mai
Beschreibung

In this role, you lead quality investigations and CAPA processeQuality Engineer InvestigationsIn this role, you lead quality investigations and CAPA processes to ensure product and process compliance. You play a key role in continuous improvement and proactive resolution of quality issues.Quality Engineer InvestigationsOur client is an international company operating in a highly regulated environment.It offers a dynamic workplace focused on innovation, quality, and operational excellence.MissionsLead 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.)Profil du candidatScientific 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 methodologiesStrong 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 integrityConditions et AvantagesInternational and high-impact working environmentStrategic role with strong visibility within a temporary assignmentOpportunities for professional development and growth within a defined mission jid274c5f3afr jit0521afr jpiy26afr

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