Have it Made Information

Interim Management Quality Regulatory professional with over 25 years of program management experience for complex integrated and regulated (medical and high tech) products. Working recently at Philips Health-Tech division ASML and Dekra, Hans has amassed knowledge across many countries and cultures needed to be successful in this function. Last 7 years acting as Free-lance Consultant and Auditor in highly complex Medical device and Semicon industry. Medical Device Lead-auditor ISO 9001 and 13485 also for Dekra. Recently Q42020 acted as an Interim QARA Manager at AQTIS a Sinclair Pharma company and improving compliancy of a group of Class III devices. Realizing improvement on MDR Supplier Controls, CAPA resolution, Change Management, MDSAP. Participating in Open-Source Scanner Project. Project management for startups and transfers related to complex integrated and regulated products. Projects included arranging sourcing, contracts, and service level agreements. Mainly from scratch but also building on the local sourcing capabilities over last 20 years. Teamed up and gave direction with suppliers in >20 countries. Semicon ASML: 2018-2021 free-lance consultant Competence Flex / NPI architect and SQE lead for production tooling for mainly Handling and Tooling department ASML. SQE/NPI Lead during 2 years for mechatronic robot arms. Co-initiator, autonomous preventive maintenance program POB and ILL tools beyond 2020. Participated in SP10 audits ASML for Supplier selection. Participated in templates dedicated to the Tooling business and automated PQR uploads by Suppliers enabling more controlled CE declarations. At Philips, Hans has finalized the Industrialization plans, supply chain setup, contracts and deliverables according to ISO13485:2016 new QMS. The program was a software proposition for a Health data platform using a smart connected IoT device. Embedded software and data management was outsourced. As the App itself. Total overview in the project.