Executive Director Design Assurance (all genders)

Olympus Surgical Technologies Europe • Other • Hamburg • 21h ago

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.

Within the Olympus Corporation, Olympus Surgical Technologies Europe (OSTE) is the global competence center for development, production and repair services for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of about 3,600 employees at 14 locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical technology and therapy and offers a full range of the most modern endoscopic applications from single products to procedure-oriented system solutions.

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.

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

Bachelor's degree in Life Sciences, Engineering or Physical Sciences (advanced technical degree and MBA preferred)
Long-standing experience in quality management or design assurance in a regulated MedTech environment, including several years in a global leadership role
Expertise in worldwide regulatory standards, such as ISO 14971, ISO 13485 and 21 CFR 820
Proven ability to design, implement and measure effective quality systems and metrics
Abiltiy to lead and mentor teams across diverse global locations while taking on full accountability, driving tasks autonomously and consistently delivering impactful results on time
Ability to drive cultural change and continuous improvement in complex organizations
Six Sigma Black Belt certification (preferred) and advanced knowledge of statistical methods and process excellence principles
Excellent communication, organization and project management, delivering results under tight deadlines
Ethical leadership with a focus on improving patient outcomes and business performance

30 days of annual leave
Up to 60% mobile work possible and 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 in-house company gym

GIMED1_DE

Apply directly

Apply

Werkstudent Global Legal & Compliance Project Support and Digitalization (w/m/d) | Beiersdorf

Beiersdorf AG • Other • Hamburg • 2h ago

SKU-jitjde2

2h ago

Apply

Importsachbearbeiter (mwd)

MEYLE AG • Other • Hamburg • 2h ago

SKU-jitjde2

2h ago

Apply

(Junior-) Softwareentwicklerin/ Softwareentwickler mit Schwerpunkt Cloud/ DevOps (w/m/d)

Informationstechnikzentrum Bund (ITZBund) • Other • Bonn, Berlin, Düsseldorf, Hamburg, Hannover, Frankfurt am Main, Ilmenau, Karlsruhe, Köln, Nürnberg, • 2h ago

SKU-jitjde2

2h ago

Apply