Henning Carstens
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Henning Carstens
- Bis heute 2 Jahre und 7 Monate, seit Apr. 2024
Senior Consultant and Partner
IQC-Group AG
Global and independent consultancy that serves medical device manufacturers, and medical device suppliers. We help on efficient implementation, optimization and compliance with new GxP regulation (e.g. MDR, FDA Computer Software Assurance), practical support in the execution and advising of validations, lean and effective quality management systems with risk management approach, Practical training in GxP topics in IQC expert webinars and in-house seminars.
- Bis heute 2 Jahre und 7 Monate, seit Apr. 2024
Qwner I Inhaber
Carstens Consulting
Business consulting for medical technology companies (life science, healthcare) with a focus on quality management, engineering, and production to provide benefit on customer-oriented, efficient problem solutions in the regulatory, qualitative, and productive areas for the production and distribution of high-quality, safe, cost-effective medical technology products.
- 8 Jahre und 10 Monate, Mai 2015 - Feb. 2024
Corporate Global RAQA Director Production & Process Controls
Stryker
Global Lead and Responsibility for Production and Process Controls incl. Process Development, Process Design, Process Risk, Validation etc., leading and advising Divisional and Operations Process Owners and Subject Matter Experts in specific production and process control areas, ensure effective, efficient, compliant and consistent practices in alignment with regulatory and financial requirements, creation, coordination and execution of relevant projects (30+ manufacturing sites, design and distribution div
- 2 Jahre und 9 Monate, Juni 2014 - Feb. 2017
Director Quality Kiel Facility
Stryker
Lead of the quality & regulatory organization at the local facility. • Local staff responsibility of 100 people. • Responsible for the site quality management system, regulatory compliance by setting strategic direction for the site while aligning to corporate and divisional systems, goals and objectives to further improve quality, time to market and cost effectiveness. • Development of Business Continuity and Disaster Recovery • Revision of Document & Change Management strategy • Developed and managed $25M
- 2 Jahre und 8 Monate, Juli 2011 - Feb. 2014
Corporate Associate Program Director and Corporate Process Owner Validation
Stryker
Global Lead and Responsibility for the companywide Validation Program • Leading and advising Subject Matter Expert teams in specific validation areas • Ensure effective, consistent and compliant validation in alignment with legal and financial requirements • Creation, Coordination and Execution of quality relevant projects (25+ sites), (10 FTE globally)
- 2010 - 2011
Divisional Manager and Process Owner Validation
Stryker
Divisional Lead and Responsibility for Validation (1 Manager)
- 2007 - 2010
Manager Maintenance and Tool Shop
Stryker
20 FTE
- 2005 - 2007
Manager Maintenance and Validation
Stryker
14 FTE
Ausbildung von Henning Carstens
- 2015 - 2021
Master Black Belt, Black Belt, Green Belt
OConsulting
- 2004 - 2008
Quality Manager and Quality Management Representative
TÜV Rheinland
Sprachen
Deutsch
C2 (Verhandlungssicher / Muttersprachlich)
Englisch
C2 (Verhandlungssicher / Muttersprachlich)
Französisch
A1-A2 (Grundkenntnisse)
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