Quality & Auditing Expert
René brings more than 20 years of management skills to Qserve in the areas of Quality Management, Research & Development, Custom made medical devices, Contract Manufacturing, Business Process Reengineering, Configuration Management and Information Technology. As (lead)-auditor he has regularly conducted ISO 9001, ISO 13485 and MDSAP audits, both internal and at suppliers.
The key expertise areas of René
- Building QMS for start-ups
- Manage complex change management and remediation projects
- Manage multi-site & multi-cultural (project) team
René about working at Qserve
"Working at Qserve for me, is being able to bounce off ideas and brainstorm with my colleagues, tap into a wealth of experience and working on the forefront of international quality and regulatory developments and apply that to the benefit of our customers".
René held various senior management positions in the Medical Device industry and Consumer Electronics. He developed and managed clinical, regulatory, and quality programs across various therapeutic areas. As a senior project manager, he was responsible for a variety of projects, ranging from the development of life-sustaining active implantable devices to multi-site product lifecycle management systems.
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