Wesley A. Bloemker

Wes Bloemker has over 45 years of experience in auditing, IT and quality and is a part-time consultant for Verista working for various Medical Device and Pharmaceutical clients. He has a unique perspective that has proven to be beneficial in dealing with a broad range of issues and innovative approaches. His experience in data management and governance allowed multiple companies to gain compliance with global regulations. Wes has led positive change which has included the modernization of new product development processes, transformation of logistics and distribution, lean management of compliant quality systems, unification of regulatory processes, identification and implementation of new processes and technology to address business and technical challenges, realignment of resources in support of corporate, regional and local strategies. Wes’ hands-on GxP experience includes directing new and enhanced quality systems, process improvements, post-market surveillance, complaint management, investigations, adverse event reporting (MedWatch, Vigilance, Pharmacovigilance and Safety), manufacturing, and quality oversight for product development, including software driven devices. Special concentration in these areas include complaint processing, corrections and removals, CAPA, change management, document control (DHF, DMR, MPR, BPR, and QMS documentation), global product registration, inspections, validation, distribution, UDI, and supplier management.