Diane Thayer Email & Phone Number

Salem, Ma

Willmington, Ma

Assigned to 4 PIT Teams as the quality representative for a specific product group. • Participated in 12 Lean Events focusing on cost reduction and process improvements, one of which reduced the process by 8 steps, created a time savings of 90 minutes, increased production, and increased revenue by $750K. • Completed a product launch of 54 products meeting all project deliverables; utilized strong communication skills with 17 different suppliers to meet a very tight timeline, overcome many barriers, and secure excellent customer satisfaction with three major retail customers.• Successfully completed many project launches following strict quality and regulatory guidelines and meeting all targets including timeline, under budget and meeting customer expectations. • Manage and guide overseas vendors with the required standards needed to launch new products in the NAFTA region. Products must pass FCC Safety, multiple UL standards, RoHS, Energy Star, PROB 65, many others dependent on product type. • Tasked by management to devise a streamlined process to consolidate legal documentation and reports providing legal, sales, and customer service departments with enhanced access to compliance documents; reduced document retrieval from 3-4 weeks to instantaneous.• Conducted in-house and Skype trainings with legal, customer service, sales, marketing departments as well as Project Managers regarding the documentation process.• Drive project critical path and identify project risks by evaluating A Sample data. Review data with vendor and R&D when product requirements may be in jeopardy.

Manchester, Nh

• Established and maintained document control practices among manufacturing facilities including creating, changing and obsoleting documents. Maintained over 30 document classifications. • Restructured the requirements for document changes by building a list of questions asking the “requester” What are you doing? Why are you doing this? What is the benefit? Has this been validated? Where is the data? Resulting in an extensive history file which became an asset for the Legal team, Process Engineering and Research and Development. • Responsible for submitting products to the FDA using the FDA Portal. • Documentation Control Specialist focusing on the following: • Created all necessary documentation for all new products for ease of manufacturing • Maintained libraries of data supporting new product launch and product re-design. • Communicated and assisted with system processes for business-critical activities• Supported manufacturing with documentation, Bill of Materials, raw materials, product documents, Standard Operating procedures, Forms, Process Flow, Visual Aides. • Distributed new and changed documents. Retrieved obsolete documents. • SAP ERP & EDOS Super User• Created and maintained Bill of Materials and Labor Routes for manufacturing • Generated and implemented a Deviation System for manufacturing • Organized and facilitated Document Review Board• Provided training and guidance in EDOS, SAP, Q Gate, OnTo Labeling, FDA Submittals