It is with pleasure that we introduce Albert Koster as a member of our expanding team of experts. Albert brings experience in Quality Management Systems and Quality assessments and will join us to strengthen the Quality Assurance Business area.
Prior to Qserve, he worked at BSI as Client Manager and Lead auditor for medical device manufacturers and is qualified for ISO 9001, ISO 13485, CMDCAS, MDD for a large range of qualification codes. In this capacity he has audited many companies across the EMEA region and subsequently gained very strong auditing skills. In his last year within BSI he completed also a range of ISO 13485:2016 transition audits and has been fully trained for the new Medical Device Single Audit Program (MDSAP).
Albert holds a Bachelor and Master of Science degree in mechanical engineering and product design. He has started his career at Nucletron, now Elekta in The Netherlands, manufacturer of radiotheraphy equipment, as a design engineer and development project manager with both non-active applicators and interfaces to active equipment. After that, he worked as consultant in product design, where he gained more hands on experience with CAD CAM design, CNC processing, injection molding and programming. However returned quickly to the medical device industry to develop again radiotherapy equipment by joining a small startup company Isodose Control (now also Elekta).
After having 10 years of medical device industry practice, he joined Qserve as a consultant in a range of quality and regulatory projects. From CE technical files, 510(k)’s, to development of quality systems, interim QA/RA management.
Now as of June 2017 he has decided to join Qserve again as Senior Consultant in order to assist manufacturers in these demanding times to comply with medical device regulations.
Now as of June 2017 he has decided to join Qserve again as Senior Consultant in order to assist manufacturers in these demanding times into comply with medical device regulations.
Jan van Lochem, CEO of Qserve, about our new colleague:
“I am very happy with Albert rejoining Qserve. For the past 3.5 years working at BSI as Client Manager / Lead Auditor across Europe, he gained invaluable experience in ISO 13485 auditing, the transition to ISO 13485:2016 and the MDSAP new audit methodology. With this expertise and insight in the state of compliance across the medical device sector in Europe, he will be of great value to Qserve customers that need to prepare themselves for all the upcoming new regulatory requirements: ISO 13485:2016, MDSAP, EU-MDR.”
For more information, please see his profile.