I work as both a product engineer and project manager for changes to our portfolio of Depth Filters used in biopharmaceuticals manufacturing. As a project manager, I work with a cross-functional team to set up a change management plan and ensure everyone involved understands their responsibilities. The team meets on a regular basis to review task progress and completion. As each phase of the project is completed, we work as a team to create a presentation and present the update to the operating committee for approval to move to the next phase. As a product engineer, I determine testing needs, analyze test data and document results, create stability studies, complete design control documents, update claims, create customer facing reports to provide data for customers that will aid in their qualification of the change, update regulatory support files and respond to customer inquiries.

Project lead and product engineering lead for changes to Zeta Plus manufacturing

Worked with team to create QMS for department and completed internal ISO audits, resulting in ISO 9001 certification in April 2014Led QA on cross-functional NPI teams for surface and sunlight delivery system projectsCreated plan, analyzed data and documented results for shelf life testing on new products or changes to existing productsWorked with team to create a test plan and analyzed data for new products to substantiate product claims Analyzed, determined root cause and responded to customer quality complaints for Fasara, Crystal and Dichroic film productsWorked with the manufacturing sites to address any quality issuesManaged quality relationship with outsourced vendors and created supplier specificationsDevised new test methods as needed

Led QA on cross-functional new product introduction (NPI) teams for Tegaderm wound and IV site dressings which met or exceeded product launch timelinesVerified all testing was completed to substantiate product claimsCreated plan, analyzed data and documented results for shelf life testing on new products or changes to existing productsAnalyzed, determined root cause and responded to customer medical and quality complaints for Tegaderm lineTracked monthly complaints for Tegaderm line and responded by working with the plant to address any quality issuesManaged quality relationship with outsourced converting siteLed qualification and completed documentation for new RM SOS or manufacturing site changes to meet necessary timelines

Provided quality assurance support for a variety of new product introduction (NPI) teams to create brightness enhancement films for LCD TV, Monitor, Notebook and Handheld device businesses Traveled to Hwaseong, Korea and Yangmei, Taiwan to work with international teams on new product qualificationsRecommended environmental testing necessary to ensure that products would survive the lifetime of the product in the harshest of conditionsCoordinated environmental testing for various qualification projects and analyzed data using Minitab statistical analysis softwareCompleted documentation for new products such as customer quality specifications, internal quality specifications and customer data packagesEvaluated thermo-mechanical, physical, and optical properties of new products to document in customer data packagesProvided support to international customers by supplying root cause analysis and corrective action for defect returns and quality issues Mentored new quality engineers in organization

Led all polyester related qualifications Coordinated trials for new RMs and made sure that the changes did not affect the quality of the productProvided quality support for manufacturing on NPI projects, resulting in four Golden Step awards ($10 MM in sales within first three years of product launch)Traveled to Naju, Korea and Yamagata, Japan to work with international teams on new product qualificationsOrganized coating trials for reformulated optical grade resinAssisted in process related improvements such as line-speed increases and re-qualification of lines after upgradesProvided support to international customers by supplying root cause analysis and corrective action for defect returns and quality issues Led production troubleshooting for all quality related issues Documented procedures and trained crews on inspection procedures

Led two successful six sigma green belt projects and worked as an active team member on several black belt projects focused on waste reduction 3P (Pollution Prevention Pays) award for green belt project Responsible for product quality of numerous different diaper tape constructions, including one of the two highest volume products Held customer contact position for one of the division's major customers Assisted production crews in troubleshooting procedures and correctly identifying defective materialConducted operator training to change waste reporting proceduresLed Coating Waste Reduction Team Utilized statistical tools such as Design of Experiments, I-MR charts, t-tests and regression analysis to aid in qualifications of new products as well as SOS changes