Senior QA Engineer - MedTech

Zest Business Group Ltd; Deutschland; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading HealthTech company in Europe is seeking a Senior QA Engineer to lead quality and compliance initiatives in a fast-growing MedTech environment. The ideal candidate will have a strong background in the medical devices sector, ensuring compliance with EU regulations, and will be passionate about driving quality improvements. This position offers a competitive and flexible remuneration package.

Leistungen

Competitive remuneration package

Qualifikationen

• Accomplished Quality professional in the Medical Devices sector.
• Hands-on experience with compliance to EU MDR & FDA QSR.
• Experience in high-growth/start-up environments is preferred.

Aufgaben

• Lead quality and compliance initiatives.
• Collaborate with engineering, manufacturing, and operations.
• Support medical device software and instrument development.

Kenntnisse

Quality Management Systems

ISO 13485

Compliance with EU MDR

Agile methodologies

Data management

Jobbeschreibung

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

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.