Tanja Victoria Brenek brings solid Medical Device Quality Process Management experience, combined with a Management- and Project Management degree.
Tanja has extensive experience managing global quality processes with 800+ users, and global projects such as transferring processes to new platforms. She has worked within the areas Quality Process Management, Quality Systems, Post Market Surveillance, QC and Operations for +20 years.
She has skills within process optimization, Complaint-, Nonconformity-, CAPA and Change Control process, workshop facilitation, LEAN, Post Market Surveillance reporting, IMDRF coding for Manufacturing Incident Reporting and process mapping.
Tanja can offer business consulting to comply with the Medical Device Directive- and Regulation, ISO13485, 21 CFR Part 820 and MDSAP.
Furthermore, Tanja is an experienced trainer and communicator, and can offer you stake holder management, change management and project management skills
We are excited to welcome Tanja to Technolution as Senior Quality Consultant.