Senior QA Engineer - MedTech

Zest Business Group; Hemel Hempstead; On-site; GBP 40,000 - 70,000; Full time

Job summary

An innovative HealthTech company is seeking a Senior QA Engineer to lead quality initiatives in medical device software development. This role is crucial for ensuring compliance with EU and FDA regulations while driving quality improvements in a fast-paced, AI-driven environment. Join a rapidly scaling MedTech firm that is transforming patient pathways with cutting-edge solutions. If you are passionate about quality management and eager to make an impact in healthcare, this is the perfect opportunity for you.

Qualifications

• Erfahrungen in der Medizintechnik mit nachgewiesener Erfolgsbilanz.
• Kenntnisse in ISO-Normen und regulatorischen Anforderungen.

Responsibilities

• Leitung von Qualitäts- und Compliance-Initiativen zur Validierung von QMS.
• Zusammenarbeit mit verschiedenen Abteilungen zur Integration von Qualitätssystemen.

Skills

Qualitätsmanagement

EU MDR Compliance

FDA QSR Compliance

ISO 13485

IEC 62304

IEC 62366

ISO 14971

Agile Methodologien

Datenmanagement

Job description

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.