As a Quality Assurance Manager (m/f/d) at Stryker, you will play a pivotal role in ensuring the highest quality standards for life-changing medical devices, directly impacting patient safety and regulatory excellence. Leading a team of skilled engineers, you will drive innovation, process optimization, and compliance in a company recognized globally for its cutting-edge technology and commitment to making healthcare better.
What You Will Do
* Lead and develop a high-performing team of 12+ quality engineers, driving strategic initiatives in quality process improvement, validation, sterility, compliance, and technology transfers.
* Oversee critical QA projects to ensure regulatory compliance (EU MDR, internal regulations) while optimizing costs and operational efficiency.
* Define and implement a forward-thinking quality system strategy aligned with business needs and global best practices.
* Drive continuous improvement initiatives, ensuring robust risk management, NC/CAPA resolution, and quality planning.
* Collaborate cross-functionally to ensure adherence to quality standards and regulatory requirements across all operations.
* Engage with internal and external audit programs, ensuring the organization maintains all necessary certifications.
* Foster a culture of compliance, knowledge sharing, and proactive problem-solving to meet current and future business challenges.
What You Will Need
* Bachelor’s or Master’s degree in Engineering, Science, or a related field.
* 2+ years of people management experience with a proven ability to lead high-skilled engineers and oversee complex quality-related projects.
* 8-9 years of technical experience within quality assurance in a highly regulated industry (medical devices, pharma, aerospace, food & beverage).
* Expertise in key quality processes, including Process Risk Management, Validation, Project Management, Non-conformance and continuous improvement etc.
* Strong interpersonal, networking, and leadership skills with a passion for continuous improvement.
* Excellent English and German language skills, enabling seamless collaboration with global stakeholders.
Preferred Qualifications:
* Certification in Quality Management (CQE, CQA, Six Sigma Green or Black belt) is nice to have.
* Experience in Sterility Assurance and Auditing is nice to have.
* Expertise in EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards is nice to have.
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 of 3 days a week on site 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.