As a Senior Quality Engineer (m/f/d) New Product Introduction, youu2019ll help bring innovative medical technologies to market by driving quality across the full product lifecycle. Based in Freiburg, youu2019ll collaborate with global teams in Germany, Puerto Rico, Poland (Skawina), and Mexico (Tijuana) to ensure new products u2014 from line extensions to novel CMF solutions (https://cmf.stryker.com/) u2014 meet the highest standards of safety and compliance. This is a 50% role and a unique opportunity to shape how life-changing devices are developed and launched. What will you do: Lead quality activities in New Product Introduction (NPI), with a focus on both line extensions and new-to-market devices Support full product lifecycle from concept to commercial launch, including risk management, validation, and inspection planning Represent Quality during design reviews, ensuring compliance with FDA, ISO 13485, and internal Stryker processes Collaborate with cross-functional teams across regions to standardize NPI processes and deliverables Support supplier qualification and PPAP activities, and support validation of external manufacturing processes Ensure robustness of quality deliverables, including DHF, PFMEA, and CAPA input as needed Utilize statistical tools to develop efficient, scalable inspection and production quality systems Communicate clearly with internal teams, suppliers, and stakeholders to ensure timely and high-quality project outcomes What will you need: _Required:_ Bacheloru2019s degree in Engineering, Life Sciences, or related technical field 2 years in Quality or Manufacturing within Medical Devices or Pharma (or other highly regulated industry). The seniority of the role may be adjusted based on your experience and qualifications Strong knowledge of risk management, PFMEA, and statistics Fluent in German and English Strong communication, initiative, and time management skills Comfortable working both independently and in a team environment _Preferred:_ Experience with supplier quality, PPAP, validation, and supplier audits Familiarity with FDA, ISO 13485, and NC/CAPA processes Exposure to design control and DHF documentation Experience in cross-functional collaboration across global teams Additional information The position is a permanent, part-time role (50% FTE - 19,5 hours). Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site of 3 days a week 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. 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 u2013 M/F/Veteran/Disability.