Ihre Aufgaben
- Manage and harmonize the global risk management process, creating effective training tools for cross-functional teams.
- Collaborate with the CTO organization to develop, deploy, and support compliant, globally aligned design control systems.
- Apply statistical methods consistently throughout engineering principles, design verification, and validation processes.
- Oversee governance frameworks to meet product quality and compliance requirements.
- Evaluate and optimize quality data systems to drive improvements across the product portfolio.
- Work with R&D, Manufacturing, Medical Safety, and Regulatory Affairs teams to resolve product development challenges and escalated issues.
- Foster a strong quality culture and mindset to align the organization with regulatory and business objectives.
- Build and maintain a Six Sigma/Lean organization to support continuous improvement initiatives in product development.
Ihre Qualifikationen
- Hold a bachelor’s degree in Life Sciences, Engineering, or Physical Sciences (advanced technical degree and MBA preferred).
- Bring 15–20 years of experience in quality management or design assurance in a regulated MedTech environment, including 5–7 years in a global leadership role.
- Demonstrate expertise in worldwide regulatory standards, such as ISO 14971, ISO 13485, and 21 CFR 820.
- Show a proven ability to design, implement, and measure effective quality systems and metrics.
- Lead and mentor teams across diverse global locations while taking on full accountability, driving tasks autonomously, and consistently deliver impactful results on time.
- Drive cultural change and continuous improvement in complex organizations.
- Leverage Six Sigma Black Belt certification (preferred) and advanced knowledge of statistical methods and process excellence principles.
- Excel in communication, organization, and project management, delivering results under tight deadlines.
- Uphold ethical leadership with a focus on improving patient outcomes and business performance.
Ihre Vorteile
-30 days of annual leave
-Up to 60% mobile work possible + flexible work time model with overtime compensation
-Holiday and Christmas bonuses
-Corporate benefits discounts for employees
-Comprehensive company pension scheme and capital-forming benefits
-Company restaurant with live cooking and healthy food (subsidized)
-Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
-Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
-Various subsidized company sports groups and access to the inhouse company gym