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Senior QA Engineer - MedTech

Zest Business Group
Posted 6 days ago, valid for 12 hours
Location

Hemel Hempstead, Hertfordshire HP11AB, England

Contract type

Full Time

In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.

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 innovation.
  • 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 with expertise in ISO 13485 and related standards, along with experience in high-growth environments.
  • The position requires hands-on experience in data management, automation, and Agile methodologies, along with a passion for driving quality improvements.
  • The company offers a competitive and flexible remuneration package, though the specific salary is not mentioned, and candidates should ideally have several years of relevant experience.

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

In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.