Quality assurance engineer
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Location:
Paris Type of contract: Unlimited
ABOUT THE ROLE
Reporting to the Quality Manager, the Quality Assurance Engineer contributes to the implementation, maintenance and continuous improvement of the Quality Management System (QMS). He/She is also responsible for managing the quality of suppliers and subcontractors, ensuring that products, processes and services comply with regulatory requirements and the company’s quality standards. KEY RESPONSABILITIES Supplier Quality Assurance Manage and oversee the supplier and subcontractor portfolio. Implement and monitor Quality Agreements. Conduct compliance audits, particularly as part of the qualification of new suppliers. Participate in the approval and qualification of suppliers and subcontractors. Monitor the quality performance of partners and implement the corresponding action plans. Quality Management System (QMS) Lead and continuously develop the Quality Management System (QMS). Manage quality documentation, including the creation, review, distribution and archiving of quality documents. Lead the Change Control process and monitor the implementation of changes. Contribute to the continuous improvement of quality processes. Non-Conformity Management and Continuous Improvement Manage customer complaints and coordinate their investigation and resolution with the relevant teams. Monitor the quality performance of subcontractors. Contribute to the management of deviations, waivers and risk assessments. Define, monitor and assess Corrective and Preventive Actions (CAPA). Contribute to continuous improvement initiatives aimed at optimizing processes and strengthening quality performance. PROFILE & COMPETENCIES Master’s degree (5-year higher education degree) in Quality, Engineering, Pharmacy or a related field. Minimum 5 years of experience in Quality Assurance within a regulated industrial environment. Proven experience in supplier quality management, audits, document management and leading a Quality Management System (QMS). Strong knowledge of Change Control processes, deviation and waiver management, CAPA and risk management. Good knowledge of applicable quality standards and regulatory requirements. Strong attention to detail, autonomy, organizational skills and ability to work cross-functionally. Excellent interpersonal skills and ability to support and guide teams in implementing quality processes and initiatives.
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