Advanced Medical Balloons (AMB) was founded in 2009 with a clear mission: #rethinkingcriticalcare. Since then, we have grown into a leading specialist in catheter technology, supplying intensive care units worldwide with high-quality medical devices. Today, AMB is part of Stryker.
At our site in Waghäusel (south of Heidelberg), an interdisciplinary team works closely together in a trust-based environment with short communication and decision-making paths. To further strengthen our quality organization, we are looking for a motivated (Senior) Quality Engineer who is passionate about quality, manufacturing excellence, and continuous improvement.
Your responsibilities
As a (Senior) Quality Engineer, you will ensure high quality standards in the serial production of innovative medical devices. Acting as a key interface between Quality, Manufacturing, and Engineering, you will actively contribute to compliance, product reliability, and continuous improvement.
* Support daily quality operations in serial manufacturing for medical devices
* Lead root cause analyses and implement corrective and preventive actions (CAPA) for quality issues arising from production and post-market feedback
* Manage and maintain quality records and activities using systems such as TrackWise and ValGenesis
* Act as a key interface between Quality, Manufacturing, and Engineering teams
* Drive and support quality improvement initiatives and cost-reduction activities
* Coordinate with suppliers on quality-related topics and support supplier issue resolution
* Contribute to regulatory and internal compliance across manufacturing processes
* Support audit readiness and participate in internal and external audits and inspections
Your profile
Required
* Bachelor's degree in Medical Engineering, Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a comparable scientific field
* At least 2 years of experience in Quality Engineering, preferably in the medical device industry
* Solid understanding of quality systems, root cause analysis, and manufacturing support
* Strong communication skills and the ability to work effectively in cross-functional teams
* A structured, solution-oriented, and proactive working style
* Fluency in German and English
Preferred
* Familiarity with ISO 13485, FDA regulations, and NC/CAPA processes
* Experience in complaint handling and post-market quality activities
* Hands-on experience with TrackWise, PLM systems, or validation management tools
* Knowledge of supplier quality management and external quality collaboration
Why join us
* Make a meaningful impact on patient care in critical care environments
* Work in a highly specialized manufacturing and quality environment
* Be part of a close-knit, interdisciplinary team with short decision-making paths
* Combine an entrepreneurial mindset with the stability of a global organization
Diversity is important to us. We welcome applications from people regardless of ethnic, national or social origin, gender, disability, age, or sexual identity.
Additional information
Please note that the internal job title may differ from the job advertisement title.