Sten Elkjær Andersen

Biography

Sten Elkjær Andersen Director Corporate Quality Assurance Engineering at Ambu A/S Ambu A/S Københavns Teknikum Sealand Region, Denmark Quality Assurance in the medical device industry. Development, maintenance and use of Quality Management systems in compliance with FDA and ISO regulations for medical device manufacturer. Performing internal and external quality audits in both Europe, Asia and USA. Expirence with- and performing training in Part 11 requirements regarding Electronic Records and Electronic Signature for software systems. Experience with- and performing training in CAPA and Complaint handling process. Implementing, maintaining and training in Risk Management Process. Training and defining Process Validation, Sterilization Validation and implementing statistical methods. 

Research Interest

Specialties: Quality Assurance Regulation according to 21 CFR FDA 820, ISO9001 and ISO13485 Electronic Records, Electronic Signature according to FDA 21 CFR Part 11 Design Controls according to 21 CFR Part 820 and ISO 13485 CAPA handling process inclusive complaint handling Auditor according to FDA and ISO quality regulations Risk Management process Process Validation techniques Statistical Methods Sterilization Validation