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