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Senior QA Engineer - MedTech

Zest Business Group
Posted a day ago, valid for 5 days
Location

Hemel Hempstead, Hertfordshire HP2 4DB, England

Salary

£80,000 - £100,000 per annum

Contract type

Full Time

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Sonic Summary

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  • Zest Scientific is seeking a Senior QA Engineer for a leading European HealthTech company focused on AI-driven medical innovations.
  • The role involves shaping the quality strategy for medical device software and ensuring compliance with EU MDR and FDA QSR regulations.
  • Candidates should have a strong background in the Medical Devices sector, ideally with 5+ years of experience in high-growth or start-up environments.
  • Expertise in ISO 13485, IEC 62304, and Agile methodologies is required, along with a passion for driving quality improvements.
  • The position offers a competitive salary and flexible remuneration package, with applications being accepted immediately.

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 & 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 & 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 management.

The Company:

  • Innovative HealthTech/MedTech company, transforming patient pathways with evidence-based solutions.
  • Rapidly scaling business, focused on early detection and preventative healthcare.

Remuneration & Application:

Our client is committed to attracting the right candidate and offers a competitive, flexible remuneration package.

Zest Scientific is working to a strict deadline - apply now to be considered immediately.

Apply now in a few quick clicks

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