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.