Inspirations for the foundation MEDICON in 2014 was mainly coordination of the activities I have had so far and I have now within my interest areas.
A multitude of projects I have been and I’m still involved giving me possibility to work with people from quality, continuous improvement, operations, manufacturing and medical devices businesses.
Experienced with Medical Devices industry within several positions in medical devices manufacturers and several years as ISO Auditor and Expert in Certification Body. Since 2006 I cooperate with medical devices manufacturers and since 2010 complementarily with certification body.
I’m looking for cooperation opportunities with Professional Certification Body specialized in Medical Devices where I’m interested in contract cooperation which could be a complementary to the actual positions I hold for medical device manufacturers.
My experience is based on multiple aspects related to operations management, manufacturing management, general quality, continuous improvement, global manufacturing and repairs structure, green field projects in EMEA, APAC and Americas.
Quality and manufacturing within medical devices industry are my specialisations, almost from the beginning of my professional work:
– Quality Management Systems complied with ISO 9001
– Quality Management Systems complied with ISO 13485
– Medical Devices Directive 93/42/EEC
– FDA 21 CFR 820
– several types of audits including internal, external, supplier’s audits and FDA inspections
On top of my experience from several years work with medical device manufacturers and cooperation with Certification Body TüV Nord I have also knowledge related to several processes required within medical devices industry like risk analyze ISO14971, guidelines for auditing management systems ISO 19011 and application of usability engineering to medical devices EN 62366.
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