Senior Quality Engineer

Work Flexibility: Hybrid or Onsite

As a Senior / Staff Quality Engineer (m/f/d) working on Stryker’s cutting-edge surgery planning solutions, you’ll play a vital role in shaping the future of pre-operative planning solutions — ultimately improving patient outcomes. Join a company driven by its mission to make healthcare better and known for its culture of integrity, accountability, collaboration, and innovation.

What will you do

• Act as the Quality expert and independent interface between product development, usability engineering, regulatory affairs, test labs, and manufacturing throughout the full product lifecycle — from concept through launch.

• Lead and coordinate design control activities including risk management (ISO 14971), design reviews, and DHF (Design History File) documentation.

• Collaborate with cross-functional teams — R&D, Systems Engineering, Usability, RA, and Software Engineers — to identify, mitigate, and control product risks.

• Guide project teams through the design control process, holding them accountable to ensure quality is built into every phase.

• Support and attend validation and usability studies, including those involving customers, to ensure risk controls are effective and compliant.

• Provide quality leadership during the development of a new system/platform.

• Contribute to continuous improvement initiatives and help ensure compliance with regulatory requirements, including FDA, MDR, ISO 13485, and other relevant standards.

What will you need

Required Qualifications:

• Bachelor’s or Master’s degree in (Bio)Medical Engineering, Electrical/Software Engineering, or a related technical field.

• 2+ years of experience in quality assurance or product development in a regulated industry (preferably medical devices).Based on years of experience the seniority of the role can be adjusted.

• Proven knowledge of risk management (ISO 14971) and design control (21 CFR 820 / MDR).

• Familiarity with software development and the software life cycle process (e.g., IEC 62304).

• Strong communication, coordination, and analytical skills, with a quality-first mindset.

• Fluent in English; comfortable working in an innovative, international environment.

Preferred Qualifications:

• German language skills are a plus.

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  

The position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position. 

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of 3 days a week on site at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments. 

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

Travel Percentage: 10%