Herbert S.

Accomplished and results driven professional specializing in quality improvement for medical firms in areas such as regulatory and quality system implementation, root cause analysis, complaints, CAPA and statistical process controls. A proven track record of maintaining and implementing ISO 13485:2016, EU requirements and QSR regulations for medical device and non medical device firms. Demonstrated the ability to communicate with top level management, customers, and front line employees in all aspects of Quality Assurance. Former Plastic Injection Molding experience for the entertainment industry and small medical device components. Excellent written and verbal skills. BILINGUAL (GERMAN)