You ensure quality operations in manufacturing by leading investigations into quality issues and coordinating with teams and suppliers to drive improvements and maintain compliance.
Anforderungen
- •Bachelor's degree in Medical Engineering
- •Minimum 2 years of experience in quality engineering
- •Solid understanding of quality systems
- •Strong communication skills
- •Structured, solution-oriented mindset
- •Fluency in German and English
- •Familiarity with ISO 13485 and FDA regulations
- •Experience with complaint handling
- •Prior experience using TrackWise or PLM systems
- •Knowledge of supplier quality
Deine Aufgaben
- •Support daily quality operations in manufacturing.
- •Lead root cause analysis for quality issues.
- •Implement corrective actions based on feedback.
- •Manage quality records using TrackWise and OnePLM.
- •Act as liaison between quality and engineering teams.
- •Drive quality improvement and cost-reduction initiatives.
- •Coordinate with suppliers on quality topics.
- •Support supplier-related issue resolution.
- •Contribute to regulatory compliance in manufacturing.
- •Support audit readiness and participate in inspections.
Original Beschreibung
# Senior / Staff Quality Engineer (m/f/d) Navigation Medical Devices
**Freiburg, Germany** | **Full time**
Work Flexibility: Not available
**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**
Travel Percentage: None