(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.

Additional information

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

Travel Percentage : None