Jobs in Bamberg, United States
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Recare Deutschland GmbH
Senior QA Engineer - MedTech
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
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
- 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.
- 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.
- 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.
- Innovative HealthTech/MedTech company, transforming patient pathways with evidence-based solutions.
- Rapidly scaling business, focused on early detection and preventative healthcare.
Our client is committed to attracting the right candidate and offers a competitive, flexible remuneration package.
* Der Gehaltsbenchmark wird auf Basis der Zielgehälter bei führenden Unternehmen in der jeweiligen Branche ermittelt und dient Premium-Nutzer:innen als Richtlinie zur Bewertung offener Positionen und als Orientierungshilfe bei Gehaltsverhandlungen. Der Gehaltsbenchmark wird nicht direkt vom Unternehmen angegeben. Er kann deutlich über bzw. unter diesem Wert liegen.