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.

• 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.