·Directed, trained and measured the effectivity of a Document Control team of 7 located across multiple states in the administration of: -1800+ ECOs, and 75,000+ engineering specification and quality document changes through SAP and SharePoint change control. -Periodic Document Reviews and Quality Management System database maintenance activities. -Electronic and hardcopy Record Retention Program for Design History Files, Lot/Batch Records, Test Reports, and other Quality Records. -Customer Service requests for record retrieval, document history, and legal discovery. -Issuing new and updated training materials through Learning Management Systems (CornerStone/FlexTraining). -Process Improvements aimed at improving efficiencies and data accuracy. ·Successfully navigated through several unannounced FDA compliance audits and participated in recertification audits for ISO 13485 and AATB as a subject matter expert. ·Investigated quality issues and determined root-causes to achieve effect

•Strategized with upper management and developed a plan to rebuild and raise the Document Control Department to industry benchmark levels and better align with company priorities. •Hired, trained and managed a team of 3 Analysts to process quality documentation and support product development through timely release of 1500+ ECOs and 50,000+ product specifications annually. •Provided expert knowledge in quality and change control requirements to develop the process for controlling labeling proofs submitted by vendors. •Slashed department spending and successfully adjusted operating budget, saving $50,000. •Designed a FDA 21 CFR Part 11 compliant, Document Change Control System using SharePoint workflows and directed IT in its construction and implementation. •Reduced the rejection of quality and engineering specification changes by 45% through institutionalizing the use of collaboration tools prior to submission. •Worked closely with IT to rebuild and streamline SAP ECO work-flows

•Supervise 4 change analysts in day to day change control operations. •Provide extensive knowledge and advise change control personnel in Avail’s US and Mexico manufacturing facilities on cGMP and ISO13485. •Coordinated training for Change Analysts in preparation for the ASQ CQIA Exam. •Worked closely with management to create quality related project documents for numerous medical devices. •Spearheaded the creation of an onsite document control center for archiving and protecting various quality documents. •Efficiently manage documents at Avail’s off-site storage facilities which include: cataloging, entering, and retrieving.

• Achieved a $20,000 cost savings at incoming inspection by performing a risk analysis of raw materials and supplier quality histories and increasing the number of raw materials eligible for Dock-to-Stock (DTS) from 40% to 60%. •Worked closely with 50+ customers to consolidate packaging and shipping materials to achieve $500,000 in cost savings. •Collaborated with management to develop a procedure to investigate and analyze all change requests by suppliers that affect quality of the final product or service while focusing on the effects of the change on costs. •Cooperate with external auditors to correct found quality issues during ISO13485 re-certification audits, regulatory FDA audits and customer audits to prevent official findings of non-conformance. •Author of several corporate quality procedures used across multiple plant facilities, related to Internal Audits, Raw Material Specifications, Supplier Purchasing Controls, Supplier Risk Management, Sterile / Non-Sterile product r

•Worked on matrix teams to create, improve, and process various quality documents including: Installation Qualifications (IQ), Operational Qualifications (OQ), Process Qualifications (PQ) and Bill of Materials (BOM). •Create raw material specifications and inspection criteria based on customer and company requirements and supplier capabilities. •Process Deviations ECOs and MCOs by verifying completeness of the change order and gaining proper internal and customer approval when required.