Quality Assurance Manager

Work Flexibility: Hybrid or Onsite

As an NPI Quality Assurance Manager (m/f/d) at Stryker, you will lead a cross-functional, multi-site team of QA Engineers dedicated to upholding the highest quality standards during New Product Introduction (NPI). This dynamic role spans our key locations in Freiburg (Germany), Cork (Ireland), and Florida (USA), where you will provide technical and strategic leadership to drive process excellence, risk management, and product success.

You will be at the forefront of global collaboration, inspiring your team to proactively implement preventive measures and continuously improve product and process designs across regions.

What will you do:

• Partner with the NPI Director and the global QA NPI team to shape and execute the overarching NPI strategy across multiple sites.

• Lead the introduction of new products, processes, and technologies at the Freiburg, Cork, and Florida facilities, ensuring alignment with global quality standards and effective process risk management.

• Optimize both new and existing product/process designs in collaboration with cross-functional and cross-regional teams to drive quality, efficiency, and scalability.

• Provide strong technical direction and people leadership to a geographically distributed QA team, fostering a culture of continuous improvement, accountability, and high performance.

• Support  new product introduction integration, maintaining compliance with industry standards and regulations.

• Advocate for the use of robust pFMEA methodologies to identify and mitigate process risks, ensuring the reliability and performance of new products.

• Strengthen relationships and facilitate effective communication with internal and external partners within Advanced Operations and GQO, ensuring successful product launches that meet regulatory requirements and team objectives.

What will you need:

Required:

• Bachelor’s Degree in Engineering, Science, or a related discipline.

• A minimum of 6 years’ experience in a regulated manufacturing environment, such as Medical Devices, Pharmaceuticals, Bio-Medical, or Automotive.

• 2+ years of experience leading and developing teams, ideally across multiple sites or regions.

• In-depth knowledge of regulatory requirements, standards, and regulations.

• Proficiency in quality tools such as Statistical Process Control (SPC), Process Control, Failure Mode and Effects Analysis (FMEA), Risk Management, Design Control, Root Cause Analysis, Poka-Yoke, and Six Sigma methodologies.

• Experience in design transfer and new product transfer processes.

• Fluency in English, with the ability to collaborate effectively with local and international teams.

Preferred:

• Proficiency in German, enhancing communication with diverse teams and stakeholders.

• Experience with ISO 13485 standards, demonstrating a strong understanding of quality management systems specific to the medical device industry.

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

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 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.