Executive Director Design Assurance (all gender)

TN Germany; Hamburg; Hybrid; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der MedTech-Branche sucht einen Executive Director für Design Assurance, der für die Harmonisierung des globalen Risikomanagementprozesses verantwortlich ist. In dieser Schlüsselrolle werden Sie Schulungswerkzeuge entwickeln und die Qualitätssicherung in der Produktentwicklung optimieren. Mit über 15 Jahren Erfahrung in der Qualitätsführung und einem starken Fokus auf regulatorische Standards werden Sie eine Kultur der kontinuierlichen Verbesserung fördern. Diese Position bietet die Möglichkeit, in einem flexiblen Arbeitsumfeld zu arbeiten, einschließlich mobiler Arbeitsoptionen und umfangreicher Unternehmensleistungen, die das Wohlbefinden der Mitarbeiter unterstützen.

Leistungen

30 Tage Jahresurlaub

Flexible Arbeitszeiten

Urlaubs- und Weihnachtsboni

Betriebliche Altersvorsorge

Subventioniertes Firmenrestaurant

Mitarbeiterunterstützungsprogramm

Subvention für öffentliche Verkehrsmittel

Zugang zum Fitnessstudio

Fahrrad- oder Auto-Leasing

Mitarbeitersportgruppen

Qualifikationen

• 15-20 Jahre Erfahrung im Qualitätsmanagement in einem regulierten MedTech-Umfeld.
• Erfahrung in der Führung globaler Teams und der Umsetzung effektiver Qualitätssysteme.

Aufgaben

• Leitung des globalen Risikomanagementprozesses und Entwicklung von Schulungswerkzeugen.
• Zusammenarbeit mit verschiedenen Teams zur Lösung von Produktentwicklungsherausforderungen.

Kenntnisse

Qualitätsmanagement

Design Assurance

Six Sigma

Statistische Methoden

Projektmanagement

Kommunikationsfähigkeiten

Ausbildung

Bachelor in Lebenswissenschaften

Master in Ingenieurwissenschaften

MBA

Jobbeschreibung

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Executive Director Design Assurance (all gender), Hamburg

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Client:

Olympus

Location:

Hamburg, Germany

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

1f8e20bcf653

Job Views:

1

Posted:

03.05.2025

Expiry Date:

17.06.2025

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Job Description:

- 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.

- 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.

-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