Henning Carstens
Senior Consultant and Partner @Iqc-Group Ag
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WORK HISTORY
Senior Consultant and Partner @Iqc-Group Ag
Global and independent consultancy that serves medical device manufacturers, pharmaceutical companies, medical device suppliers, and biotechnology businesses.We help Manufacturers of Medical Devices, Manufacturers of pharmaceuticals, API, excipients, and Health care companies for1. Efficient implementation and compliance with new GxP regulation (e.g. MDR, FDA Computer Software Assurance)2. Practical support in the execution and advising of validations (processes, computerized systems, IT - infrastructures, data integrity, transport and packaging validations)3. Compile lean and compliant technical Files for CE-Mark, FDA submissions as 510(k), PMA, Clinical Evaluations, PMS, and European Authorized Representative for Medical Devices4. Optimization for lean and effective quality management systems according to ISO 13485 and FDA QSR with risk management approach5. Practical training in GxP topics in IQC expert webinars and in-house seminars.
EDUCATION
Medizinisch-technische Akademie Esslingen am Neckar
Lehrgang, Kontinuierliches Optimieren der Kosten und der Produktionsabläufe
Hochschule für Angewandte Wissenschaften (HAW Kiel)
Diplom-Ingenieur, Mechatronik, Robotik und Automatisierungstechnik
OConsulting
Master Black Belt, Black Belt, Green Belt, Lean Six Sigma
Management Circle
Lehrgang, Kosteneffiziente Weg zur Null-Fehler-Produktion
TÜV Rheinland
Quality Manager and Quality Management Representative
TÜV Product Service
Quality System Auditor nach 9001
SKILLS
ABOUT HENNING CARSTENS
With over 30 years of experience in leading global and local quality, regulatory, engineering and operations teams, I am a passionate, strategic leader who strives to drive innovation, excellence, and transformation in the medical device industry. My mission is to leverage my expertise in new product and technology development, engineering excellence, production performance and digital transformation to create value for customers, stakeholders, and employees. As a global director at Stryker, one of the world\'s leading medical technology companies, I was proud to be part of a diverse and inclusive culture that fosters collaboration, empowerment, and growth.In my most recent role, I had global quality management system responsibility for managing production & process control & optimization, measurement system and inspection, risk management, validation and future leading methods like lean six sigma to drive quality excellence, organizational and people growth.Over multiple years my teams and I have been awarded for innovation, quality and cost optimization by executive leadership.I am passionate about people, their strengths and optimizing quality and business processes while driving transformation and excellence.
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