RENÁTA

Medical Devices, Pharma

Lead Auditor conducted 100+ quality audits according to standards ISO 13485, ISO 9001, GMP, FDA 21 CFR 820. More than 17 years experience. 

JOSEF

Medical Devices, Pharma

Quality Manager, Medical device consultant, ISO 13485 auditor. 15 years working in medical device and pharmaceutical business. Experience in biotechnologies, aseptic production, electro-optical systems, X-ray imaging and others at positions in quality production management and sales.

MARTINA

Automotive, stavebnictví, strojírenství aj.

Quality & EHS Manager, ISO 9001 Certified Auditor, IATF 16949, ISO 14001 and ISO 45001 Auditor, VDA 6.3 Certified Auditor, VDA Maturity Level Assurance for new parts, Failure Analysis field 

PAVLA

Automotive

Audits according to ISO 9001:2015 (Lead Auditor), IATF 16949, VDA 6.3,  ISO 14001, VDA standards, QS standards, customer requirements. Risks and opportunities in ISO 9001:2015.

PETR

Medical Devices

GMP Qualified Person, GDP Responsible Person
GMP auditor of Czech and Slovak hospital´s transfusion centers, ISO 9001& GDP auditor Regulatory (registration & notification) for medicinal products and medical devices.

PAVEL

FMCG, finance, automotive

Internal auditor and compliance officer with experience in risk based auditing and compliance management in global organizations in the professional services network, food retailer, automotive and consumer credit industries.

JAN

Software, Medical Devices

A conscientious quality and validation specialist with over 9 years experience in regulated industry, 7 of these years as validation/quality specialist in medical device and pharmaceutical/food industry, lately focused on Software quality and validation and CSV.