Quality Engineer | Life Sciences (H/F)

La mission

As a Quality Engineer in the Life Sciences sector, you will play a key role in maintaining and improving quality systems, ensuring regulatory compliance, and supporting continuous improvement initiatives across pharmaceutical and biotech environments. In this role you will play a key role in: - Developing, implementing, and maintaining quality management systems (QMS) in accordance with GMP guidelines and relevant regulatory frameworks such as ISO 13485, FDA 21 CFR, and EU GMP, ensuring full compliance across all quality processes. - Leading and supporting quality assurance and quality control activities, including batch record reviews, product release, change control, deviation management, and CAPA processes to ensure consistent product quality. - Conducting internal and external audits to assess compliance with regulatory requirements and company quality standards, identifying areas for improvement and driving corrective actions to closure. - Collaborating with cross-functional teams including manufacturing, validation, regulatory affairs, and supply chain to embed a culture of quality and ensure seamless integration of quality requirements throughout the product lifecycle. - Preparing and reviewing quality documentation such as SOPs, risk assessments, audit reports, and quality metrics, ensuring all documentation is accurate, up-to-date, and audit-ready for regulatory inspections by bodies such as the FDA, EMA, and FAMHP.