Zabel Consulting Services LLC

Product Stewardship: RoHS, REACH, CE, CA-65 Compliance Reviewer, Trainer, Auditor • European Directives 2002/95/EC; 2002/96/EC, 2011/65/EU, 2015/863 * • California Safe Drinking Water and Toxic Enforcement Act of 1986 - Prop 65 * • Conflict Minerals Directives 2014/95 and 2017/821/EU; Dodd Frank Act 1502 ASSISTANCE WITH AUDITING, INSPECTIONS, REGULATORY COMPLIANCE, CERTIFICATION, TRAINING CE Marking, ATEX, RoHS, auditing suppliers - quality, sustainability, 7S (5S, 6S), social compliance. • QUALITY ENGINEER: CAPA - 8-D, 7 Step, 5 Why, FDA 21CFR 820 (ISO 13485), MDMP, RCA • INTERNAL AUDIT/STANDARD UPGRADE • NEW STANDARDS/REVISIONS - Implement systems, procedures assuring compliance; coordinate processes, train engineers, obtain supporting documentation • SCRUM PROJECTS: generate value while coordinating teams to address complex adaptive problems to productively and creatively deliver products of the highest possible value. • SUPPLIER ASSESSMENTS - PPAPs, FAI/R (First Article Inspection/Reports), FMEAs; NFPA 101, risk assessments, documentation; FDA 483 resolution, IO/OP/PQ; Value Stream Mapping