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Permanent

Senior QA Engineer - MedTech

Hemel Hempstead
money-bag 80000.00-80000.00 Annual
2919658100
Posted 3 weeks ago

Zest Scientific is partnering with a leading European HealthTech to identify a Senior QA Engineer. This is a unique opportunity to join a fast-growing MedTech business at the forefront of AI-driven innovation, enhancing diagnostic accuracy, advancing treatment pathways, and improving clinical outcomes. As part of the Quality and Compliance team, you will play a pivotal role in shaping the quality strategy for cutting-edge medical device software and instrument development. You will ensure cross-functional collaboration across engineering, manufacturing, and operations, implementing robust QMS principles in a high-growth, innovation-driven environment. The Candidate: Accomplished Quality professional with a strong track record in the Medical Devices sector, ensuring compliance with EU MDR and FDA QSR regulations.Expertise in ISO 13485, IEC 62304, IEC 62366, and ISO 14971.Experience in high-growth/start-up environments, ideally within an international, remote-first engineering team.Hands-on experience with data management, automation, and Agile methodologies.Passionate about driving quality improvements and championing change.Location: Europe. The Role: Lead quality and compliance initiatives, ensuring QMS validation and automation of software testing.Collaborate cross-functionally with engineering, manufacturing, and operations to integrate quality systems across business processes.Support medical device software and instrument development, ensuring best practices in quality ..... full job details .....

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