Barry Fischer

Senior Quality Manager @Hydranautics - A Nitto Group Company

Oceanside, CA, US
MOBILE NUMBERS
+18•••••••56

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WORK HISTORY

Jan 2018 — Present

Senior Quality Manager @Hydranautics - A Nitto Group Company

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San Diego, CA, US

Leader of ISO9001:2015 Quality Management System operations, Analytical chemical testing, and Reliability inspection/testing operations for 10-person organization:• Led the implementation of equipment and process validation (IQ/OQ/PQ) systems for both local and outsourced manufacturing facilities• Drove the adoption and incorporation of best-practice multi-phase product design verification and validation for all new products and product design changes• Implemented risk-based controls for supplier/outsourced process quality controls, incoming QC inspection (including critical chemicals), ‘4M’ process changes, and site audits• Successfully completed 2 ISO9001:2015 recertification audits as well as ongoing annual audits; also maintained NSF/ANSI 61, 21CFR177, EC 1935/2004, EU 10/2011, Kosher, and Halal compliance

EDUCATION

1995 — 1997

University of North Carolina Wilmington

M.B.A., Business, emphasis in Finance

1982 — 1986

University of California, Berkeley

B.S, Nuclear Engineering

SKILLS

Chemical EngineeringLean TransformationSupply ManagementContinuous ImprovementQuality ControlProduct DevelopmentAnalysisOperations ManagementKaizenEngineering ManagementFailure AnalysisTestingMaterials ManagementCross-Functional Team LeadershipSupplier QualityQuality SystemLean ManufacturingSupply ChainFmeaIso 13485BiotechnologyProcess EngineeringEngineeringAerospaceSupply Chain ManagementStrategic SourcingPolymersR&DManagementProject ManagementCapaIso 9000Manufacturing Operations ManagementIsoFdaDesign of ExperimentsManufacturingDesign for ManufacturingQuality AssuranceManufacturing Operations

ABOUT BARRY FISCHER

I am a Quality and Operations Management professional who leads quality and productivity improvements in a multitude of challenging industries: biotechnology, water & process purification technologies, aviation, nuclear energy and financial services. Consistent record leading and facilitating projects to enhance profitability by $0.5MM to 2MM per year, typically through scrap reduction, productivity improvements, and supplier quality improvement and cost reductions.Key areas of expertise:• Lean 6 Sigma, analytical problem solving, root cause analysis (RCA), CAPA• Quality Assurance, ISO 9001, ISO 13485, cGMP, 21CFR820• Manufacturing – continuous flow, assembly• Process quality control and engineering• Supplier quality, supply chain management• Financial analysis and forecasting I have successfully delivered results in following environments:• post-acquisition integration• restructuring and consolidation• scale-up and ramp-up growth – startup company and post-acquisition• highly-regulated industries – biopharma/medical device, aviation, nuclear energy• aggressive cost-reduction environment (material, labor, overhead)• remediating unacceptably high cost-of-quality (low yields)

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