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

PowerToFly; Waghäusel; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A leading medical device company located in Waghäusel is seeking a motivated (Senior) Quality Engineer to ensure high quality standards in the production of innovative medical devices. This role requires at least 2 years of Quality Engineering experience, a Bachelor’s in a related field, and fluency in both German and English. Join a close-knit team where you can make a meaningful impact on patient care while benefiting from the support of a global organization.

Leistungen

Make a meaningful impact on patient care

Work in a highly specialized environment

Entrepreneurial mindset with global stability

Qualifikationen

• At least 2 years of experience in Quality Engineering, preferably in the medical device industry.
• A structured, solution-oriented, and proactive working style.

Aufgaben

• Ensure high quality standards in the serial production of innovative medical devices.
• Lead root cause analyses and implement corrective actions for quality issues.
• Support audit readiness and participate in internal and external audits.

Kenntnisse

Quality systems

Root cause analysis

Manufacturing support

Strong communication skills

Fluency in German

Fluency in English

Ausbildung

Bachelor’s degree in Medical Engineering or related field

Tools

TrackWise

PLM systems

Jobbeschreibung

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.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.