Quality Engineer Investigations
📋 Détails de l'offre
In 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 Investigations
Our client is an international company operating in a highly regulated environment.
It offers a dynamic workplace focused on innovation, quality, and operational excellence.
Missions
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Lead and coordinate the CAPA (Corrective and Preventive Actions) system
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Conduct thorough investigations and root cause analyses
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Manage non-conformance processes (NCMR) end-to-end
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Facilitate CAPA review boards and collaborate with internal and external stakeholders
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Define, implement, and monitor corrective and preventive action plans
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Track quality metrics and identify improvement opportunities
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Apply problem-solving methodologies (Ishikawa, DMAIC, Lean tools)
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Drive continuous improvement initiatives across quality processes
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Support supplier investigations and monitor supplier performance
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Contribute to internal and external audits (preparation, execution, follow-up)
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Ensure compliance with international regulations (ISO, FDA, MDR, etc.)
Profil du candidat
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Scientific degree (engineering, life sciences, pharmacy, or equivalent)
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3-5 years of background in Quality Assurance within a regulated environment
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Experience in medical devices or pharmaceutical industry
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Strong knowledge of ISO 13485, FDA, MDD/MDR regulations
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Expertise in CAPA, non-conformance management, and investigations
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Proficiency in root cause analysis tools and Lean methodologies
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Strong project management and prioritization skills
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Good command of quality systems and IT tools (MS Office, QMS software)
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Excellent communication and cross-functional collaboration skills
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Fluent in French and good level of English
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Analytical mindset, attention to detail, and high integrity
Conditions et Avantages
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International and high-impact working environment
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Strategic role with strong visibility within a temporary assignment
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Opportunities for professional development and growth within a defined mission
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🏢 À propos de l'entreprise
Entreprise dans le secteur Assurances