Kerry Nixon

Background

About Kerry Nixon

Over 30 years experience working with Medical Device Manufacturing includes: Industrial Engineering, Process Engineering, Packaging Engineering and Quality Engineering. Regulatory Affairs support includes MDR submission, CAPA and Complaint review for MDR. Experienced as a CAPA Coordinator, IQ OQ PQ Validation/Verification Engineer. Remediation support for ISO & FDA regulations, customer complaint gap analysis and documentation. 3 years experience FDA compliance with Health Supplements. Specialties: FDA 21 CFR Parts 11 (ER;ES), 58 (GLP non-clinical), 210 (cGMP Manufacturing, Processing, Packaging), 803/806 (MDR & corrections), and especially 820 (QSR)~ ISO 13485 (QMS). Equipment and Process Validation, Supplier Quality Audit, Internal Quality Audit, CAPA system management. Goal: Sense meeting FDA regulatory requirements is the right thing to do, my specialty is to help companies meet and maintain compliance. Validation is simply the documented evidence of good engineering. I am lookin for a long term permanent position in Utah where I can use my valuable Prcess Engineering, RA/QA remediation experience. Until the contract work keeps me very busy.