Randy C. Agness

*** ******** *****

Fairport, New York 14450

315-***-**** / adukj0@r.postjobfree.com

PROFESSIONAL EXPERIENCE

West Port Fuel Systems Vancouver, BC Canada (2/2022 – 7/2022) Senior Supplier Quality Engineer

Responsible for Supplier Quality, Audit supplier shipments for approval. Corrective and preventative actions with suppliers utilizing problem-solving. On-site source evaluations. Collaboration on supply and demand management. Technical support, reporting results through SharePoint software.

Alstom Corporation Henrietta, NY (10/2021 – 2/2022) Senior Supplier Quality Engineer

Responsible for Supplier Quality, Audit supplier shipments for approval. Corrective and preventative actions with suppliers utilizing problem-solving. On-site source evaluations. Collaboration on supply and demand management. Reporting results through SharePoint software.

Agness Engineering Fairport, NY (1/2020 – 10/2021) Technical Consultant

Freelance consultant. Internal auditing, support, and technical quality training. Project review and problem troubleshooting. Process engineering. Supported PPAP and FAI reporting. Quality training for staff on Incoming, In-Process, and Final Inspection. Training on Defect Detection and proper use of measurement instrumentation. Xerox Corporation Webster, NY (7/2019 – 12/2019)

Imaging Engineer

Responsible for Supplier Quality Management, Project review and project problem-solving. Equipment procurement. Production cell redesign. Process optimization and continuous improvement activities. Arconic Engines Rochester, NY (1/2018 –2/2019)

Quality Engineer

Responsible for providing product certification for forged Aerospace Engine Components to meeting International Aviation Standards.

• Provide sustaining Root Cause and Corrective Actions for non-conforming product.

• Manage Zero Defect program activities for major clients to improve first time yields.

• Act on Supplier Quality issues to improve performance in the areas of defect recognition, dimensional analysis and part marking.

• Complete client first article submissions for new product and for drawing revisions. Provide fixed process outlines for product manufacturing.

• Create, document and implement inspection criteria and procedures.

• Point of contact to interact with customers and vendors to ensure quality of purchased and finished products.

• Review operational procedures to current revisions and provide training for production employees. Bausch + Lomb Rochester, NY (8/2016 – 9/2017)

Senior Quality Systems Analyst

Responsible for providing quality support and validation of the Global Document Management System to meet FDA 21CFR Part 11, 820, 203, 206, 803, 806, ISO-9001:2008 and ISO-13485:2016. Review structure and content advisor for Documentum D2 Quality Management System for change requests, Kintana and SharePoint software proficiency. Involved in all 3rd Party Audits.

• Developed the QSE FAQ list to provide Users better understand how to effectively process change requests. Developed metrics consistent with FDA Guidance defining data integrity to tract the First Time Through (FTT) processing indicating document type and percentage of processing errors, trouble-shooting User issues and providing trend analysis and risk analysis.

• Subject Matter Expert providing user training on Quality Management System, support audit remediation, and develop competency measures for efficiency, effectiveness and compliance. VirtualScopics Rochester, NY (1/2016 – 5/2016)

Quality / Validation Engineer

Responsible for providing quality support and validation of production (CT, MRI, ECHO, X-ray scans) operations, ensuring the integrity cGMP’s and content meets the FDA 21CFR 11 and International client sponsor’s study delivery specifications.

• Complete CAPA / NC investigation and provide sustainable corrective action plans, root cause analysis and product disposition. Leads Internal Auditing and review of standard operating procedures for compliance.

• Supports equipment and process validation by participating in the development of studies protocol and validation to assess manufacturing capability and reliability to the delivery criteria. Ortho Clinical Diagnostics Rochester, NY (9/2015 – 1/2016) Quality / Validation Engineer

Responsible for providing quality support to production operations of FDA In Vitro Diagnostic of chemistry and immunodiagnostic blood and urine analyzers, ensuring the integrity of components and products purchased from sub suppliers meet engineering and performance specifications and operational requirements for Multi-National clients.

• Executes functions needed to support change control and document management.

• Process disposition transactions and review DHS records for product release.

• Accreditations – FDA 21 CFR 820, 803, 806, Part 11 and EU Directives 98/79 Rochling-Advent Rochester, NY (3/2014 – 5/2015)

Quality Engineer

Responsible for production operations of FDA Cardiovascular, Surgical Instruments, Orthopedics, Insulin delivery medical devices and sub- assemblies, supplier quality improvements, receiving quality testing, quality staff technical training and clean room medical assembly quality systems for multinational clients.

• Provided support for both ISO-9001:2008, ISO-13485, FDA 21CFR 820, TS-16949 including Medical and Automotive audits preparation and employee technical training.

• Completed CAPA / NCR investigations including root cause analysis, and complete corrective action plans for internal operations, medical device components and customer non-conformance issues.

• Lead continuous improvement projects, process reliability, improve quality and provide cost reduction.

• Responsible for PPAP’s including gage R&R, capability studies, SOP’s for IQ, OQ and PQ projects.

• Provided technical expertise as a Subject Matter Expertise for Production Operations.

• Document, and maintain quality control standards concerning on-going quality control objectives including the quality inspection and product release programs for incoming, in-process and finished goods.

•

Berry Plastics Corporation Macedon, NY (9/2013 –3/2014) Process Engineer – Plastics

Responsible for process improvements for productivity and downtime reduction, setup changeover time and scrap reduction and process monitor.

• Interface with customers on root cause analysis and corrective action for major customers.

• Review the daily product testing and process control parameters and provide technical support.

• Develop continuous improvement project management for raw materials and cost saving along with employee training programs.

• ISO Internal Auditor and responsible for continuous improvement programs.

• Provide inspection oversee activities for product throughout production processes.

• Understand quality mission and provide interpretation to key personnel across operational departments. Jasco Tools, Inc. Rochester, NY

Quality & Compliance Manager (11/2004 – 9/2013)

Manage Quality Assurance and Environment, Safety and Health for a multiple plant organization. Achieved consecutive ISO-9001:2008, TS-16949 and NADCAP AS9100 and ITAR surveillance and re-accreditation audits without non- conformances for multinational client base and Advance Product Quality Planning.

• Provided technical support including, product testing, process measurement and processing condition for Salt, Vacuum and Tempering Heat Treating operations along with CNC Mill and CNC Lathe processes and Precision Laser machining of sheet metal.

• Responsible for all aspects of the quality management system, employee safety and skills training.

• Certified Six Sigma Green Belt and trained in instrument calibration.

• Completed root cause analysis, scrap reduction and activities to increase productivity.

• Conducted continuous improvement projects and effectiveness of corrective actions.

• Managed the APQP process and completed Automotive Production Part Approval Process (PPAP)

• Document and analyze statistical data as well as product specifications for determining standards and to establish quality reliability expectancy of finished products and packaging requirements.

• Conducted Site safety audits and inventory control of hazardous materials & hazardous waste.

• Reduced the number and severity of injuries and accidents annually to below industry standards.

• Responsible for Supplier Quality, experience in operation of CMM equipment, and employee training.

• Certified Aerospace Internal Auditor, ISO Internal Auditor, Corrective & Preventive Action, RCA

• Certified OSHA Safety & Health Specialist, OSHA General Industry Trainer

• Follow established metrics to track, trend and report on quality incidents and to measure performance improvements;

• Budgetary responsibility for the Quality Department at two locations.

• Supervise quality personnel engaged in inspection and testing activities to ensure conformity to GMP’s.

• Maintain technical integrity by following ISO and other industry standard to high productivity and track scrap %. EDUCATION

Concentration Enology & Viticulture Finger Lakes CC Geneva, New York Master of Science – Business Oswego State University Oswego, New York Bachelor of Science – Chemistry Saint Bonaventure University Olean, New York Internal Auditing Specialist PRI- NADCAP, ISO-9001:2008, TS-16949, ISO-13485 Six Sigma Green Belt SKF-GE Program

Safety & Health Specialist / Trainer RIT – OSHA

ASSOCIATIONS & ADJUNCT TEACHING EXPERIENCE

Member, American Society for Quality

Member, Society of Plastics Engineers (Past President) Rochester Institute of Technology Adjunct Professor Plastic Processing Monroe Community College Adjunct Professor Plastics Technology ADVANCED COMPUTER TRAINING

Proficient in Microsoft Professional Office, MS Project, Minitab, SAP, OTIS, SyteLine, TrackWise, Documentum, ComplianceWire, Kintana, SharePoint.

Contact this candidate