● Project lead for global change control activities for supplier changes, value improvement projects and raw material qualification. o Translated cost savings ideas into business cases with detailed project plans and financial benefits.● Project Manager for multilayer extrusion requalification. Mitigated supply continuity risk and preventing material stock-out for four downstream facilities.● DMAIC Instructor, coach and mentor for prospective Lean 6α green belts and project engineers. ● Led automated visual inspection pilot in extrusion and identified parameter improvements that resulted in a 20% increase to detection capability.● Designed and directed studies to identify significant factors and demonstrate statistical equivalence.

• Supported global activities for risk management and file generation for legacy base solutionproducts in flexible containers• Provided quality oversight on product design changes, supplier changes, new equipment installation, and test methods validation.• Quality engineering project support for new product development, design verification studies and legacy design history file (DHF) remediation activities.• Applied DMAIC and green belt problem solving tools to reduce false signals in post markettrending by over 50%.• Provided coaching for contingent labor and new hires on change control and post markettrending processes.

• Performed risk based analysis of Batch and Product Family complaint data to determine the need for Corrective/Preventive Action, Field Corrective Actions (FCA) and/or the recall of nonconforming product. o Aided in the development of an automated tool for monitoring lot performance using established risk threshold values. • Reviewed Complaint Investigations to ensure complete and thorough investigation of the allegation.• Implemented Change Requests to ensure that the categorical reporting of complaint data aligned with Global Corporate Quality procedures for trending purposes.• Led monthly review of Product Quality data to investigate new and aging adverse product complaint trends.

• Investigated atypical events and processing excursions within vaccine sterile packaging operations to determine root cause, assess potential product impact, and evaluate necessary remedial and/or Corrective/Preventive actions (CAPA).. o Closed 10% of all Investigations authored ahead of schedule.• Authored remediation protocol for minor defects which enabled recovery of $1.5MM+ of saleable product within 1 year. • Designed experimental studies to assess dissolved gas content within source bulk and its relationship to internal and external customer complaints.• Developed, assigned, implemented and oversaw CAPA action items including changes to manufacturing culture, equipment improvements, experimental studies, and mechanical repairs.• Designed and implemented a visual control board for investigation tracking to better understand where process deficiencies exist in order to reduce cycle-time metric of investigation closure.

• Oversaw compliance and acquisition of OHSAS 18001 & ISO 14001 certifications.• Implemented a centralized complete Material Safety Data Sheet (MSDS) library for the manufacturing facilities to improve worker safety, designed to meet both US OSHA and International OHSAS 18001 requirements.• Conducted safety and CAPA audits to update manufacturing standards in the spray painting, vacuum pressure impregnation and injection molding tooling processes. Remedial actions included sourcing and purchasing new PPE (including respiratory protection), as well as training employees.• Performed site wide review of Standard Operating Procedures to comply with 21 CFR 820 FDA medical device regulations.• Managed a team of Ruby on Rails developers to create eastekinternational.com and wah-tsun.com, and was responsible for overseeing graphics production, image sourcing, copywriting and copy editing.

• Evaluated process and material changes with lab scaling for new and existing batches.• Executed production, pilot, and laboratory scale-up/scale-down for DoE purposes.• Helped define and evaluate safety requirements using chemical compatibility, HAZOP and LOPA.• Reduced new equipment costs by $30,000 via restoration, repair, and calibration of existing but damaged peristaltic and dual piston pumps. Repairs included valve rebuilds and piston reassembly.• Researched potential lab and pilot plant purchases, including sizing and field testing an IKA in-line homogenization unit for pilot production.

• Monitored environmental data for NOx and SOx production in FCC flue gas. Developed emission correlations which were tested and validated by statistical analysis using Minitab software.• Implemented a tracking system for supplemental crude oil blends sent to the Fluidized Catalytic Cracking (FCC) unit using Visual Basic and PI process flow diagrams.• Updated existing process flow diagrams with PLC data to improve real-time monitoring and control of Process Control Systems with PI Processbook.