Henk-Willem has over 15 years of experience in setting up, maintaining and improving Business and Quality Management Systems (QMS) based on ISO 9001, ISO 13485, MDD 93/42/EEC, and FDA 21 CFR 820 Quality System regulations. In addition, he is a seasoned expert in Computerized System Validation (CSV) and 21 CFR Part 11.
In the recent past, he has been managing CSV validation programs and responsible for deployment and management of QMS processes including Training Management, Corrective and Preventive Action (CAPA) Management, Change, Document & Record Control and Management Review.
Henk-Willem holds a Master degree in Analytical Chemistry (MSc) and a bachelor in Laboratory Informatics & Automation.
Prior to Qserve, Henk-Willem worked for a various consulting company as a consultant, and as a project- quality- and compliance manager.
In these roles, he advised clients and managed projects in the chemical, pharmaceutical and medical device industry in the area of IT, quality and regulatory compliance. He also acts as (internal) lead auditor ISO 9001 and ISO 13485 for medical devices companies.
Learn more about our services within Quality Assurance