Senior / Staff Quality Engineer (m/f/d) Navigation Medical Devices
Senior / Staff Quality Engineer (m/f/d) Navigation Medical Devices
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Job Description
As a Senior or Staff Quality Engineer in Strykers Navigation Business Unit (Freiburg) youll 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 youll 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:
Bachelors 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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Travel Percentage: 10%Required Experience:
Staff IC
Employment Type
Full-Time
