Freiburg, Germany
35 days ago
Senior / Staff Quality Engineer (m/f/d) Navigation Medical Devices
Work Flexibility: Onsite

As a Senior or Staff Quality Engineer in Stryker’s Navigation Business Unit (Freiburg), you’ll ensure top-quality standards in the serial production of advanced electronic medical devices — including navigation platforms, tracking tools, and ablation technologies. Acting as a key link between quality and manufacturing, you'll drive reliability, compliance, and continuous improvement across a global, cross-functional environment.

What will you do:

Support daily quality operations in serial manufacturing for navigation systems and devices

Lead root cause analysis and implement corrective actions for quality issues from production and post-market feedback

Manage and maintain quality records and activities using systems like TrackWise, OnePLM, and ValGenesis

Act as a key liaison between quality, manufacturing, and engineering teams

Drive and support quality improvement and cost-reduction initiatives

Coordinate with suppliers on quality topics and support supplier-related issue resolution

Contribute to regulatory and internal compliance across manufacturing processes

Support audit readiness and participate in inspections as needed

What will you need:

Required:

Bachelor’s degree in Medical Engineering, Electrical, Mechanical, Industrial Engineering or in a comparable scientific field.

Minimum 2 years of experience in quality engineering, preferably in the medical device industry. The seniority of the role may be adjusted based on your experience and qualifications

Solid understanding of quality systems, root cause analysis, and manufacturing support

Strong communication skills and ability to work effectively across teams

Structured, solution-oriented, and proactive mindset

Fluency in German and English

Preferred:

Familiarity with ISO 13485, FDA regulations, and NC/CAPA processes

Experience with complaint handling and post-market quality

Prior experience using TrackWise, PLM systems, or validation management tools

Knowledge of supplier quality and external quality collaboration

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity. 

Additional information  

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

Travel Percentage: 10%

Por favor confirme su dirección de correo electrónico: Send Email