Senior / Staff Quality Engineer (m/f/d) Navigation Medical Devices

Stryker Group; Freiburg im Breisgau; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in the medical devices sector is seeking a Senior or Staff Quality Engineer in Freiburg. You will ensure quality standards and compliance in the production of advanced electronic medical devices. The role involves driving quality improvement initiatives and coordinating across multiple teams while supporting audit readiness and regulatory compliance.

Qualifikationen

• Minimum 2 years experience in quality engineering, preferably in medical device.
• Solid understanding of quality systems and root cause analysis.
• Fluency in German and English.

Aufgaben

• Support daily quality operations in serial manufacturing for navigation systems.
• Lead root cause analysis and implement corrective actions.
• Manage quality records using systems like TrackWise and OnePLM.

Kenntnisse

Strong communication skills

Structured mindset

Solution-oriented mindset

Proactive mindset

Ausbildung

Bachelor’s degree in Medical Engineering or similar

Tools

TrackWise

OnePLM

ValGenesis

Jobbeschreibung

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

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