John R. Schultz 1009 Abbey Lane Apt. 7

Erie, PA 16502

Cell Phone: 717-808-2732 Email: schultzykins@gmail.com

PROFESSIONAL PROFILE

Quality Assurance Scientist & Engineer dedicated to improving processes and products via quality tools, sound logic, and cross functional teamwork. My over twenty years of diverse experience and skills in the quality arena is founded on the core principle of going above and beyond to serve the customer with superior products and service. Mar. 2016 – Sept. 2016 Quality Assurance Engineer Essentra Components – Erie, PA

Lead investigator for customer complaint resolution in a plastics injection molding facility.

Conduct CAPA investigations for customer complaints using 8D methodology for automotive, aerospace, and electronics industry customers.

Disposition quarantined product via daily management meetings and MRB.

Support APQP and PPAP teams. Oct. 2013 – Oct. 2015 Quality Manager / Engineer Cybersonics, Inc. Erie, PA

ISO 13485 / 9001 Quality Management System experience with an Ultrasonic Medical Device OEM of Olympus Surgical Technologies, C.R. Bard, and Penumbra, Inc. products.

Managed incoming part inspections, measurement tool calibrations, and equipment maintenance.

Reviewed and approved in-process work orders and final device release test records.

Managed sterilization and packaging validation project for ShockPulse-SE Lithotripsy System.

Hosted notified body surveillance audits and factory inspections (TUV-SUD America).

Conducted Internal Audits of processes (Work Instructions and Standard Operating Procedures).

Conducted Supplier Quality System Audits for Critical Component manufacturers.

Managed Non-Conforming product review at MRB meetings, CAPA system, and SCARs.

Reviewed controlled documents via Change Control process in the Document Control Database (Synergy and QT9).

Conducted weekly training sessions for Production Associates and Engineers. Feb. 2013 – Jul. 2013 Services Productivity Engineer Project Leader – 6 Month Contract CDI Corporation at General Electric Transportation Systems, Erie, PA

Led frequency reduction projects resulting in cost savings to Maintenance Service Agreements for major railroad customers.

Used the Tollgate process to track and manage project milestones and timelines.

Employed statistical tools such as Weibull and Crow to predict project viability and failure rates. Oct. 2011 – Oct. 2012 Quality Engineer – 12 Month Contract Groupware Solutions, Inc. at General Electric Transportation Systems, Erie, PA

Performed Quality audits and inspections of locomotive components and parts for internal and external packagers.

Advised quarantine and disposition of defective product.

Maintained quality metrics for the locomotive export kitting operation.

Updated Global Inventory part descriptions in Oracle.

Supported 100% inspection of new programs / accounts via Dashboard Metrics.

Supported customer cases via CAPA process.

John R. Schultz 1009 Abbey Lane Apt. 7

Erie, PA 16502

Cell Phone: 717-808-2732 Email: schultzykins@gmail.com

Apr. 2000 – Jan. 2010 Senior Quality Assurance Analyst Johnson & Johnson – Merck Consumer Pharmaceuticals, Lancaster, PA

Conducted Quality investigations including Root Cause Analysis / Corrective and Preventative Action and advised product disposition.

Worked with suppliers via audit and specification requirements.

Drafted technical protocols and Standard Operating Procedures.

Executed validation of equipment and test methods.

Participated and implemented Six Sigma / Process Excellence projects and training including Lean, Kaizen, 5S, and Mistake-Proofing in a GMP manufacturing facility. Yellow Belt trained and certified. Green Belt project team member.

Key contributor on HACCP action teams.

Led and participated in FDA, ISO, and environmental compliance audits.

Effectively supervised the department when necessary.

Led plant-wide training sessions.

Implemented effective Change Control.

Contributing member of the Global Quality Leadership Team for the entire Johnson & Johnson Consumer products network.

Represented the department at Daily Process Review, Management Action Review, R&D, and various project team meetings.

___________________________________________________________________ KEY BUSINESS RESULTS

Saved ~$250,000 annually by bringing outside contracted testing in house.

Developed risk management plan to reduce excess material sampling and testing resulting in cost savings.

Created and developed risk classification tool for raw materials to aid in laboratory / manufacturing investigations for the Johnson & Johnson network.

Drafted Johnson & Johnson World Wide standardized procedures on a global, cross-functional team to develop company-wide best practices.

___________________________________________________________________ AWARDS

Johnson & Johnson ACT Award for Lean Initiative Tools

Johnson & Johnson Standards of Leadership Award for Business Diversity

Johnson & Johnson Collaborator of the Month Award

Various Johnson & Johnson Encore Award nominations

_____________________________________________________________________ EDUCATION

Bachelor of Science in Biochemistry, The Pennsylvania State University, 1995

Member of National Registry of Certified Microbiologists, American Society of Microbiology, 2009

COMPUTER SKILLS Windows 7, MS Word, Excel, PowerPoint, Access

Beckman Laboratory Information Management System (LIMS)

SAP / Oracle - Product / material tracking and laboratory investigation database

Enterprise Document Management System (EDM) – SOP database & Change Control

REFERENCES Available upon request.