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Quality Engineer
🇫🇷France·31 mai·1 min de lecture

Quality Engineer

PS
Pionra Sources
@pionra-sources · 142 vues

Join a fast-growing medical device startup as a Quality Engineer. In this role, you will own and improve the Quality Management System (QMS), drive manufacturing quality activities, lead investigations, support process validation, and collaborate cross-functionally. This is an opportunity to make a real impact in a dynamic startup environment. Own and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements. Drive manufacturing quality activities with suppliers and contract manufacturers, and lead CAPA, non-conformance, root cause investigations, and change control activities. Collaborate cross-functionally with R&D, operations, and external partners to ensure product quality from development to production. ### What We’re Looking For * Bachelor’s or Master’s degree in Engineering or a related technical field. * 2–4 years of experience in Quality within medical devices or another regulated industry. * Solid understanding of ISO 13485, supplier quality, CAPA, and manufacturing quality systems. * Languages: English is mandatory, and Mandarin Chinese is a strong plus. * Pragmatic, detail-oriented, and comfortable taking ownership. * Strong communication skills and ability to work in a fast-paced environment. * Startup mindset: adaptable, proactive, and eager to build. * Willingness to travel occasionally to supplier sites and contract manufacturers in Europe and Asia. Quality Engineer chez Hinlab à Paris.

Source originale: https://www.welcometothejungle.com/fr/jobs/quality-engineer_paris Source: Welcome to the Jungle

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Join a fast-growing medical device startup as a Quality Engineer. In this role, you will own and improve the Quality Management System (QMS), drive manufacturing quality activities, lead investigations, support process validation, and collaborate cross-functionally. This is an opportunity to make a real impact in a dynamic startup environment. Own and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements. Drive manufacturing quality activities with suppliers and contract manufacturers, and lead CAPA, non-conformance, root cause investigations, and change control activities. Collaborate cross-functionally with R&D, operations, and external partners to ensure product quality from development to production. ### What We’re Looking For * Bachelor’s or Master’s degree in Engineering or a related technical field. * 2–4 years of experience in Quality within medical devices or another regulated industry. * Solid understanding of ISO 13485, supplier quality, CAPA, and manufacturing quality systems. * Languages: English is mandatory, and Mandarin Chinese is a strong plus. * Pragmatic, detail-oriented, and comfortable taking ownership. * Strong communication skills and ability to work in a fast-paced environment. * Startup mindset: adaptable, proactive, and eager to build. * Willingness to travel occasionally to supplier sites and contract manufacturers in Europe and Asia. Quality Engineer chez Hinlab à Paris.

Source originale: https://www.welcometothejungle.com/fr/jobs/quality-engineer_paris Source: Welcome to the Jungle

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