Introduction
eucatech AG, a member of the OrbusNeich Group, is an internationally oriented medical device company specializing in the development and manufacturing of innovative vascular products. To strengthen our Quality department, we are looking for an experienced professional who can contribute with technical depth and international interface skills to our Quality Management and Regulatory Affairs activities at the Weil am Rhein site. This position reports directly to the Quality Manager.
Your Responsibilities
* Maintain and further develop the Quality Management System in accordance with ISO 13485, MDR, and other applicable standards
* Prepare, review, and approve SOPs, work instructions, and other quality documents
* Manage CAPAs, changes, deviations, and non-conformities
* Manufacturing Quality Assurance (MQA): Ensure regulatory compliance (ISO 13485, MDR, FDA) within production processes
* Design Quality Assurance (DQA): Ensure compliance with design requirements (MDR, FDA, ISO 13485) through design controls, verification activities, and independent documentation review
* Conduct and support internal and external audits (e.g., Notified Body, FDA, customer audits)
* Manage and update technical documentation for our medical devices
* Support national and international regulatory submissions (e.g., MDR, FDA)
* Collaborate closely with production in process controls, risk assessments (FMEA), and validations
* Train and advise internal departments on regulatory requirements and quality standards
* Communicate and coordinate with our Head Office on global quality and regulatory topics
Your Profile
* Degree in Medical Technology, Life Sciences, Regulatory Affairs, Quality Management, or a comparable field
* Several years of professional experience in a regulated environment, ideally in the medical device or related industry
* Solid knowledge of MDR, ISO 13485, 21 CFR Part 820, and experience with technical documentation
* Proficient in using quality and ERP systems (e.g., SAP, TrackWise, SharePoint)
* Excellent communication skills in both German and English (written and spoken)
* Structured and precise working style with strong process orientation
* Desirable: Experience in sterilization processes (e.g., EtO, E-beam) and cardiovascular medical devices (especially catheters)
We Offer
* A responsible role with wide scope for action in an international medical device company
* Participation in exciting quality and regulatory projects
* Close collaboration with interdisciplinary teams and our Head Office
* Option for mobile working
* 30 vacation days and attractive compensation