Stefanie Hirsch

Stefanie Hirsch Email and Phone Number

Chief Sustainability and Quality Officer - Member of the Executive Board @ Dräger
Lübeck, SH, DE
Stefanie Hirsch's Location
Lübeck, Schleswig-Holstein, Germany, Germany
About Stefanie Hirsch

Since 1889, we at Dräger are turning technology into “Technology for Life”. We take responsibility every day - for the quality of our products, the environment, our employees, and society. This responsibility drives our sustainability efforts. The Dräger family motto, “Lever Schaden as Schimp” (better a loss than a disgrace), has shaped us for over 135 years and five generations. Our actions aim to benefit not just people but humanity. Every day, we strive to make the world a little better.Personally, it is a matter of the heart for me to contribute to the health and well-being of others through my daily efforts. I am passionate about sharing my experiences and lessons learned with young professionals, especially female leaders or those aspiring to become leaders. I am convinced that diverse perspectives are essential for continuous improvement, and I am committed to contributing to this diversity.As Chief Sustainability & Quality Officer, I collaborate with our entire organization to drive sustainability and quality to the next level and into the future. In the past year, we have expanded our sustainability organization, and in the upcoming months and years, we will launch additional measures to enhance our sustainability and profitability. With our “Technology for Life”, we protect, support, and save lives globally, giving our work a deeper meaning and embedding sustainability into our business model.

Stefanie Hirsch's Current Company Details
Dräger

Dräger

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Chief Sustainability and Quality Officer - Member of the Executive Board
Lübeck, SH, DE
Website:
draeger.com
Employees:
10810
Stefanie Hirsch Work Experience Details
  • Dräger
    Chief Sustainability And Quality Officer - Member Of The Executive Board
    Dräger
    Lübeck, Sh, De
  • Dräger
    Chief Sustainability & Quality Officer - Member Of The Executive Board
    Dräger Jul 2024 - Present
    Lübeck, Schleswig-Holstein, De
    Develop and implement corporate sustainability and quality strategy and policies with focus on healthcare, occupational safety, environmental protection and supply chains. Develop sustainability and quality programs, ensuring compliance with regulations, reporting requirements and customer expectations. Raise future sustainable practices and projects. Build organizational capabilities and drive culture of awareness and commitment to sustainability and quality ensuring focus on ESG principles and regulatory frameworks. Guide the organization’s strategic direction, operations, and overall performance. Promote ongoing dialogue with internal and external stakeholders in order to develop constructive, transparent relationships.
  • Dräger
    President Quality & Regulatory Affairs
    Dräger Jan 2020 - Jun 2024
    Lübeck, Schleswig-Holstein, De
    Global leadership of the Quality Management System and Regulatory Affairs. Continuous improvement of the quality management system to sustainably support the business strategy and values of the company. Regulatory strategy development and implementation. Development and implementation of initiatives for further strategic direction of the company regarding quality and customer satisfaction. Drive culture of awareness and commitment to Quality ensuring focus on patient safety and product quality.
  • Dräger
    Vice President Quality & Regulatory Affairs
    Dräger Sep 2018 - Dec 2019
    Lübeck, Schleswig-Holstein, De
    Global leadership of the Quality Management System and Regulatory Affairs. Continuous improvement of the quality management system to sustainably support the business strategy and values of the company. Regulatory strategy development and implementation. Development and implementation of initiatives for further strategic direction of the company regarding quality and customer satisfaction.
  • Drägerwerk Ag & Co. Kgaa
    Member Of The Supervisory Board
    Drägerwerk Ag & Co. Kgaa May 2023 - Jun 2024
  • Ortho Clinical Diagnostics
    Senior Director Quality & Regulatory Affairs Emea & Aspac
    Ortho Clinical Diagnostics Sep 2017 - Aug 2018
    Raritan, Nj, Us
    Region-wide leadership for implementing and continuously improving Quality, Regulatory Affairs and compliance for EMEA and ASPAC commercial affiliates. Develop regulatory strategies, policies, guidelines, programs, procedures, investigative approaches and metrics to track performance and compliance.
  • Ortho Clinical Diagnostics
    Director Quality & Regulatory Affairs Emea
    Ortho Clinical Diagnostics Sep 2016 - Sep 2017
    Raritan, Nj, Us
    Region-wide leadership of Quality and Regulatory Affairs team. Develop regulatory strategies, policies, procedures and metrics to track performance. Implement, maintain and continuously improve Quality Management System.
  • Abbott Diagnostics
    Senior Manager Regulatory Affairs – Asia / Pacific
    Abbott Diagnostics Jan 2015 - Aug 2016
    Abbott Park, Illinois, Us
    Lead implementation of Medical Device regulations and national requirements for business in Asia Pacific. Develop regulatory strategies and drive device approvals. Management of affiliate compliance activities.
  • Abbott Diagnostics
    Manager Quality - Quality Site Head
    Abbott Diagnostics Aug 2011 - Dec 2014
    Abbott Park, Illinois, Us
    Lead Quality Organization of manufacturing and distribution site (Class I, II, and III medical devices).
  • Abbott Diagnostics
    Technical Product Manager
    Abbott Diagnostics Jun 2010 - Jul 2011
    Abbott Park, Illinois, Us
    Lead technical operation and production activities for in-vitro diagnostic products. New product launches, product life cycle management and manufacturing site transfers. Identify and drive cost improvements.
  • Abbott Diagnostics
    Manager Auditing And Quality Consulting
    Abbott Diagnostics Nov 2009 - Jun 2010
    Abbott Park, Illinois, Us
    Management of US FDA readiness activities to achieve initial US FDA Certification. Organization and execution of external Quality System assessments/audits including Supplier Control. Development and leadership of Quality Improvement Initiatives.
  • Abbott Diagnostics
    Quality System Manager
    Abbott Diagnostics Jul 2008 - Nov 2009
    Abbott Park, Illinois, Us
    Lead Quality System department (Auditing, Documentation, Training, CAPA/Metrics, Calibration). Establish and execute Internal and External Audit program. Establish and execute Quality Improvement Initiatives.
  • Abbott Diagnostics
    Manager Pqa, Regulatory Affairs And Auditing
    Abbott Diagnostics Jul 2006 - Jun 2008
    Abbott Park, Illinois, Us
    Implementation and maintenance of complaint handling system, vigilance / post-market surveillance and internal audit program for new manufacturing site. International product registrations and notifications.
  • Abbott Diagnostics
    Transfer Project Manager
    Abbott Diagnostics Mar 2003 - Jun 2006
    Abbott Park, Illinois, Us
    Manufacturing transfer of diagnostic products and rare reagents between manufacturing sites. Management of Third-Party-Manufacturer (TPM) “distributed by” projects.
  • Abbott Diagnostics
    Quality Assurance Senior Specialist
    Abbott Diagnostics Jul 2001 - Feb 2003
    Abbott Park, Illinois, Us
    Quality assurance of new product development and reformulation projects of in-vitro diagnostic products. Assessment and approval of design control documents and design verification / design validation studies.
  • Abbott Diagnostics
    Research Technician Within R&D
    Abbott Diagnostics Feb 2000 - Jun 2001
    Abbott Park, Illinois, Us
    Product development / improvement projects of in-vitro diagnostic products in compliance with GMP / ISO standards and international design control requirements.
  • Roche
    Placement Student
    Roche 1996 - 1997
    Switzerland 🇨🇭 , Ch
    In-vitro toxicology studies, establishment and maintenance of animal and human hepatocyte cell lines, internal drug development studies

Stefanie Hirsch Skills

Medizinprodukte Design Control Entwurfskontrolle Projektmanagement Mdr Gmp Udi Iso Unternehmensstrategie Biotechnology Regulatory Affairs Pharmaindustrie Validation Medical Devices Quality Assurance Arzneimittelzulassung Forschung Und Entwicklung V&v Big Data Cross Functional Team Leadership Management Strategische Planung Capa Sop Big Data Analytics Iso 13485 Kontinuierliche Verbesserung

Stefanie Hirsch Education Details

  • Hochschule Mannheim
    Hochschule Mannheim
    Biotechnologie

Frequently Asked Questions about Stefanie Hirsch

What company does Stefanie Hirsch work for?

Stefanie Hirsch works for Dräger

What is Stefanie Hirsch's role at the current company?

Stefanie Hirsch's current role is Chief Sustainability and Quality Officer - Member of the Executive Board.

What schools did Stefanie Hirsch attend?

Stefanie Hirsch attended Hochschule Mannheim.

What skills is Stefanie Hirsch known for?

Stefanie Hirsch has skills like Medizinprodukte, Design Control, Entwurfskontrolle, Projektmanagement, Mdr, Gmp, Udi, Iso, Unternehmensstrategie, Biotechnology, Regulatory Affairs, Pharmaindustrie.

Who are Stefanie Hirsch's colleagues?

Stefanie Hirsch's colleagues are Doreen Barry, Ulrike Myrau, Thomas Rodewaldt, Emma Sofía Martinez De Velazquez, Hanlon, Jim, Olga Emets, Marjorie Wilkins.

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