Senior QA Engineer - MedTech

Zest Business Group Ltd; Paris; Hybride; EUR 80 000 - 100 000; Plein temps

Résumé du poste

An innovative HealthTech company is seeking a Senior QA Engineer to join their Quality & Compliance team. This is a unique opportunity to play a pivotal role in shaping the quality strategy for cutting-edge medical device software and instruments. You will lead quality initiatives and ensure compliance with industry regulations while collaborating across engineering, manufacturing, and operations. The company is rapidly scaling and focused on transforming patient pathways with evidence-based solutions. If you are passionate about driving quality improvements in a dynamic environment, this role is perfect for you.

Qualifications

• Strong track record in Medical Devices sector ensuring compliance with EU MDR & FDA QSR.
• Experience in high-growth/start-up environments, ideally remote-first.

Responsabilités

• Lead quality and compliance initiatives, ensuring QMS validation.
• Collaborate cross-functionally to integrate quality systems across processes.

Connaissances

Quality Assurance

Medical Devices Compliance

ISO 13485

Agile Methodologies

Data Management

Description du poste

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.