Senior QA Engineer - MedTech

Stellenbeschreibung:

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.