Barry Fischer Email & Phone Number

San Diego, California, Us

San Diego, Ca, Us

Lead Corporate QA team responsible for managing all Corrective/Preventive action (CAPA) and Internal Quality Audits for 2500-person organization (1 design site, 2 manufacturing sites and 15 global service and distribution hubs):• Reduced CAPA backlog of aged records by 32% in first four months, with backlog at zero after 8 months, closure performance surpassed Company goal (90% on-time) by end of April 2017• Successfully remediated prior CAPA program shortcomings through 6-month project, revised procedures and methods, provided training to key site personnel• Participated in and led internal audits to ISO 13485 and 21CFR820, filled in 7-month Lead Auditor gap to ensure compliance with Quality System requirements• Drove 4 regulatory-related Preventive Actions through implementation, all were compliance risks due to 2+ years aging (with delayed completion)

Burlington, Ma, Us

Manages Quality Control and Quality Assurance teams, supporting San Diego and Temecula sites, in accordance with ISO 9001, ISO 13485, and 21CFR820 standards (for in-vitro diagnostic products), as well as Corporate and Divisional cGMP standards. Major accomplishments:• Improved the major quality systems in San Diego, including QC inspection, testing, discrepancies, and complaint resolution, resulting in QC cycle time reduction and improved customer satisfaction• Co-led formal Corrective Action project to address product labeling quality escapes in Final Production area, resulting in zero escapes 2015-16 YTD• Process owner and lead for the harmonization of labeling, QC inspection/testing, and QA processes for the 2015 site consolidation into Temecula• Site lead (300+ employees) for successful TrackWise Deviation system implementation

Yeongdeungpo-Gu, Seoul, Kr

• Improved manufacturing yield by 20% between 2011 and 2013, by leading and facilitating continuous improvements by Manufacturing and Development teams • Initiated Quality System development, in preparation for ISO 9001 certification• Built supply chain of 25+ direct suppliers and 10+ critical indirect suppliers, drove negotiations to reduce unit material cost by 22% between 2012 and 2014• Orchestrated all in-process quality controls, monitoring key measurements from entire production process, from raw material receipt through finished goods and shipment.• Oversees failure analysis of non-conforming and customer return material, uses findings to implement immediate corrective action or propose improvement projects

Yeongdeungpo-Gu, Seoul, Kr

Established flat sheet membrane and element manufacturing operation for this startup advanced-technology company:• Built initial manufacturing and operations support team of 50+ employees to enable manufacturing ramp up from zero to $7MM within 3 ½ year period• Collaborated with R&D scientists to establish procedures and quality controls to successfully transition membrane from lab to production scale• Built processes for safety, process quality, supplier quality, bill-of-material design, raw/finished good inventory and WIP management

Boston, Ma, Us

Led all Quality Assurance activities at the Vista plant: ISO-9001 compliance, supplier and internal process audits, customer issue resolution, and cost-of-quality improvements:• Achieved 18% reduction in scrap rate in 1Q’2010, resulting in over $100K in direct productivity savings, through process of scrap review and follow-up corrective actions• Championed global rollout of new customer issue tracking tool in 2009, to significantly reduce complaint resolution time (previously had been over 30 days)• Maintained site compliance to ISO 9001, NSF/ANSI 58 and 61, FDA 21CFR177 with no major audit findings

Boston, Ma, Us

Managed 24/7 operation producing reverse osmosis, nanofiltration, and ultrafiltration membranes; included all aspects of operations management in 40+ person department – people, safety, quality, and productivity:• Reduced scrap rate by $161K per year between 2006 and 2009, through ongoing process of continuous improvement• Accomplished a 50% capacity increase in 2007 through $1.4MM capital project, improving product quality and consistency – 8-month payback• Implemented new organizational structure to improve operator technical skills – significantly improved quality (20% of total scrap reduction)• Achieved significant safety improvement of zero OSHA Recordable injuries in 2009 (down from five in 2008 and two each in previous years)

Boston, Ma, Us

Completed two key projects and training on this 18-month assignment:• Reduced mechanical scrap by $573K per year through the implementation of expanded, optimized operating controls on the coating equipment• Increased plant capacity by 9% (worth $514K per year) by improving asset utilization on a major coating machine, achieved through improvements to equipment and process operating set points• Mentored Green Belts on 4 projects resulting in over $600K direct margin savings, taught formal classroom courses and tutored 9 Green Belt trainees

Cincinnati, Oh, Us

Led the finance team for $200MM facility, performed cost/margin analysis, ledger account reconciliations, inventory analysis, cash, accounts receivable, accounts payable, payroll, as well as extensive reporting.• Significantly improved accuracy and predictability of monthly closing process by upgrading the method for allocating variable overhead, preventing any year-end surprises• Developed tool for detailed tracking of production employee overtime and utilization on a weekly basis, helping the production departments to save $200-300K per year• Led initiative to improve account profitability, gaining at least $1MM-2MM per year additional revenue through more effective contract management

Norwalk, Ct, Us

Led 8-person team that oversaw quality control and process improvements for a 200+ person loan servicing unit.

Schenectady, Ny, Us

As Technical Program Manager (1995-1999), I supervised or performed all nuclear fuel engineering and project activities for a major commercial boiling water reactor (BWR) customer over four year period, a $25MM/year account.• Consistently exceeded utility customer expectations on work delivery and quality, achieving 150% improvement in on-time performance of engineering work over a four-year period. • Led fuel engineering on project that successfully restarted an idle reactor (after 14+ year shutdown)• Led all fuel-related project tasks to deliver plant upgrade projects valued at over $1 million per year.

Washington, Dc, Us

Naval Officer in Surface Nuclear Power Program, served on USS Arkansas (CGN-41) 1988-1991, held Secret Clearance. Achieved rank of Lieutenant.

B.S, Nuclear Engineering

M.B.A., Business, Emphasis In Finance