Peter Frenken
About Peter Frenken
Peter Frenken is a Senior Quality Engineer currently working at ONWARD in Eindhoven, Netherlands. He has over 15 years of experience in quality management systems across various industries, including medical devices, and has held multiple roles in quality assurance and regulatory affairs.
Current Role at Onward
Peter Frenken serves as a Senior Quality Engineer at ONWARD, a position he has held since 2021. In this role, he focuses on ensuring quality standards are met within the organization. His expertise in quality engineering contributes to the development and maintenance of quality management systems, aligning with regulatory requirements in the medical device industry.
Previous Experience in Quality Management
Prior to his current role, Peter held various positions in quality management across multiple organizations. He worked as an Interim QC/QA Manager at IME Medical Electrospinning for five months in 2020. Additionally, he served as a QESHC Coordinator at Rhenus Logistics in 2019 and as an Interim QA/RA Manager at Agilent Technologies from 2018 to 2019. His experience includes significant roles at Philips, where he worked as a Q&R Consultant and Quality Assurance Manager.
Educational Background and Certifications
Peter studied at Fontys University of Applied Sciences, where he earned a degree in Electronics from 1999 to 2002. He also completed a Bachelor's Degree in Business Administration at Fontys Hogescholen from 2013 to 2014. He is certified in EU Medical Device Regulatory Affairs, which complements his extensive experience in the medical device sector.
Expertise in Quality Management Systems
Peter specializes in quality management system (QMS) software validation, particularly concerning FDA and EU requirements, including Part 11 and GAMP 5. He promotes continuous improvement within organizations by enhancing employee awareness of customer requirements and quality objectives. His expertise extends to acting as a lead auditor for ISO9001 and ISO13485 standards.
Entrepreneurship and Consulting
Since 2017, Peter has been the owner of Frenken Quality Solutions, where he provides consulting services in quality management. His extensive background in both medical and non-medical fields, along with over 15 years of experience in production, development, and QMS environments for class I, II, and III devices, informs his consulting approach.