(Senior) Quality Engineer

Work Flexibility: OnsiteAdvanced 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 devicesLead root cause analyses and implement corrective and preventive actions (CAPA) for quality issues arising from production and post-market feedbackManage and maintain quality records and activities using systems such as TrackWise and ValGenesisAct as a key interface between Quality, Manufacturing, and Engineering teamsDrive and support quality improvement initiatives and cost-reduction activitiesCoordinate with suppliers on quality-related topics and support supplier issue resolutionContribute to regulatory and internal compliance across manufacturing processesSupport audit readiness and participate in internal and external audits and inspectionsYour profileRequiredBachelor’s degree in Medical Engineering, Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a comparable scientific fieldAt least 2 years of experience in Quality Engineering, preferably in the medical device industrySolid understanding of quality systems, root cause analysis, and manufacturing supportStrong communication skills and the ability to work effectively in cross-functional teamsA structured, solution-oriented, and proactive working styleFluency in German and EnglishPreferredFamiliarity with ISO 13485, FDA regulations, and NC/CAPA processesExperience in complaint handling and post-market quality activitiesHands-on experience with TrackWise, PLM systems, or validation management toolsKnowledge of supplier quality management and external quality collaborationWhy join usMake a meaningful impact on patient care in critical care environmentsWork in a highly specialized manufacturing and quality environmentBe part of a close-knit, interdisciplinary team with short decision-making pathsCombine an entrepreneurial mindset with the stability of a global organizationDiversity is important to us. We welcome applications from people regardless of ethnic, national or social origin, gender, disability, age, or sexual identity.Additional informationPlease note that the internal job title may differ from the job advertisement title.Travel Percentage: None