(Senior) Quality Engineer (m/w/d) Medizintechnik

Work Flexibility: Onsite

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.

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• Please note that the internal job title may differ from the job advertisement title.

Travel Percentage: None