As a **Senior Quality Assurance Engineer** , you will play a key role within the Global QA Team, ensuring that our Quality Management System meets all legal, corporate, and regulatory standards (ISO 13485, EU MDR, FDA, etc.) for all the Stryker products. You will own and continuously improve QMS processes, act as a liaison for the CDC during change and improvement initiatives, and drive process excellence across the organization. **Key Responsibilities** **Own and maintain QMS processes, including Training, Document and Record Control.** + Support and lead activities related to non-conformances and Corrective and Preventive Actions. + Develop, implement, and monitor QA processes, providing regular updates to stakeholders. + Drive **Continuous Improvement** and **LEAN initiatives** in collaboration with internal and external partners. + Support **internal and external audits** and ensure compliance with regulatory requirements. + Lead QA efforts related to Value Added Services such as labeling, kitting, and other CDC operations. + **Collaborate with cross-functional teams** and design divisions on new process setups, M&A integrations, and organizational change. + Act as a quality ambassador, promoting risk management, process discipline, and a culture of excellence. **Requirements** **Required:** + You have at least a Bachelor’s degree (or equivalent) in Engineering, Quality or a related technical field. + Minimum **3 years of experienc** **e in Quality Assurance** within a **regulated industry** (medical devices preferred). + Strong understanding of **ISO 13485, EU MDR, and FDA QSR** requirements. + **Proven experience applying** **LEAN / Six Sigma** or similar continuous improvement methodologies (Green Belt or higher). + Excellent **analytical, problem-solving, and communication skills** . + Strong attention to detail, with a structured and proactive approach. + Fluent in **English** (written and spoken). Any other language is a plus. **Preferred:** + Experience working in a **medical device distribution or manufacturing environment** . + Prior involvement in **M&A integrations** or multi-division quality initiatives. + Familiarity with **process automation tools** or digital QMS platforms. + Advanced knowledge of MS Office, especially Excel. **Why Join Us?** At Stryker, you will be part of a global team dedicated to improving healthcare through innovation and excellence. This role offers the opportunity to work in a dynamic environment, influence key quality initiatives, and grow within a culture that values collaboration, integrity, and continuous improvement. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.