Quality Assurance Manager (m/f/d) – Medical Device Manufacturing

As the Quality Assurance Manager (m/f/d) at our Stryker plant in Kiel/Schönkirchen, you will report to the Senior Manager of Quality and collaborate closely with cross-functional teams across Operations, R&D, and Regulatory Affairs. You will lead a local quality team of 6 to 10 professionals and ensure product and process compliance in a highly regulated environment. This is a people leadership role with opportunities to influence decisions, drive quality culture, and develop your team while working in a fast-paced manufacturing setting.

What will you do:

• Lead and develop a high-performing team of 6-10 quality professionals, driving strategic initiatives in quality process improvement, validation, compliance, and technology transfers.

• Oversee critical QA projects to ensure regulatory compliance 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.

• Collaborate with internal and external stakeholders to prioritize tasks, escalate risks, and ensure timely communication.

What will you need:

Required:

• A university- level Bachelor’s degree in Engineering, Science, or related field.

• 8+ years of professional experience in a highly regulated industry (e.g. Medtech, Pharma, Food, Automotive or other highly regulated manufacturing environment)

• 2+ years of experience in people leadership.

• Strong understanding of quality principles in manufacturing environments.

• Expertise in key quality processes, including Process Risk Management, Validation, Project Management, Non-conformance and continuous improvement etc.

• Strong decision-making and prioritization abilities, especially in dynamic, fast-paced manufacturing settings.

• Excellent communication and interpersonal skills.

• Fluent in English and German, enabling seamless collaboration with global stakeholders.

Preferred:

• Expertise in EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards.

• Certification in Quality Management (CQE, CQA, Six Sigma Green or Black belt).

• Experience working with international authorities during audits/inspections.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.