Henk-Willem has over 15 years of experience in setting up, maintaining, improving and auditing Business and Quality Management Systems (QMS) based on ISO 9001, ISO 13485, MDD / MDR, MDSAP, and FDA 21 CFR 820 QSR. In addition, he is a seasoned expert in (QMS) software application validation.
The key expertise areas of Henk-Willem
- Implementing and maintaining Quality Management Systems
- Performing ISO 13485, MDSAP and FDA QSR (mock) audits and inspections
- Implementing and executing QMS software application validation
Henk-Willem about working at Qserve
“It is a great pleasure and privilege to work in a global team of experts with a dedicated focus to support our clients to improve medical device performance and patient safety, applying a real practical approach.”
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. In the recent past, he has been managing software application validation programs and responsible for deployment and management of Quality Management Systems.
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