Executive Director Design Assurance (all gender)

Executive Director Design Assurance (all gender)

Olympus Winter & Ibe GmbH (OWI) Medical Systems from 01.03.2025, fulltime position, unlimited contract

We are seeking a visionary Executive Director, Design Assurance, to lead a global team of 10–15 professionals, including 6–8 direct reports comprising Directors, Senior Managers, Principal Engineers, and Data Scientists. In this role, you will ensure top-quality standards, drive compliance, and foster innovation across our product development and regulatory practices. Collaborating with cross-functional teams worldwide, you will play a critical role in achieving excellence and delivering impactful results.

Your Responsibilities

1. Manage and harmonize the global risk management process, creating effective training tools for cross-functional teams.
2. Collaborate with the CTO organization to develop, deploy, and support compliant, globally aligned design control systems.
3. Apply statistical methods consistently throughout engineering principles, design verification, and validation processes.
4. Oversee governance frameworks to meet product quality and compliance requirements.
5. Evaluate and optimize quality data systems to drive improvements across the product portfolio.
6. Work with R&D, Manufacturing, Medical Safety, and Regulatory Affairs teams to resolve product development challenges and escalated issues.
7. Foster a strong quality culture and mindset to align the organization with regulatory and business objectives.
8. Build and maintain a Six Sigma/Lean organization to support continuous improvement initiatives in product development.

Your Qualifications

1. Hold a bachelor’s degree in Life Sciences, Engineering, or Physical Sciences (advanced technical degree and MBA preferred).
2. 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.
3. Demonstrate expertise in worldwide regulatory standards, such as ISO 14971, ISO 13485, and 21 CFR 820.
4. Show a proven ability to design, implement, and measure effective quality systems and metrics.
5. Lead and mentor teams across diverse global locations while taking on full accountability, driving tasks autonomously, and consistently delivering impactful results on time.
6. Drive cultural change and continuous improvement in complex organizations.
7. Leverage Six Sigma Black Belt certification (preferred) and advanced knowledge of statistical methods and process excellence principles.
8. Excel in communication, organization, and project management, delivering results under tight deadlines.
9. Uphold ethical leadership with a focus on improving patient outcomes and business performance.

Your Benefits

1. 30 days of annual leave
2. Up to 60% mobile work possible + flexible work time model with overtime compensation
3. Holiday and Christmas bonuses
4. Corporate benefits discounts for employees
5. Comprehensive company pension scheme and capital-forming benefits
6. Company restaurant with live cooking and healthy food (subsidized)
7. Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
8. Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
9. Various subsidized company sports groups and access to the inhouse company gym

About Olympus

At Olympus, we are committed to our purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit www.olympus-europa.com and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA.

Further Information

Valuing diverse perspectives and lifestyles is one of our core values. We would therefore like to encourage all people to apply – regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age as well as sexual orientation and identity.