SUMMARY:

I am a detail oriented Quality Engineer, Process Engineer, and Manufacturing Engineer with years of day to day hands - on experience in both Large and Small Manufacturing operations, following Medical, Automotive, and Aerospace standards. I use Statistical Analysis tools to qualify tooling and processes, and track Product and Process Quality improvements. A flexible Project Leader with experience interacting across all levels of the company from management to shop floor. I managed multi-functional Quality and Process improvement team projects, including product out-sourcing and in-sourcing. Maintained Supplier Quality relationships for parts, chemicals, and purchased assemblies. I specialize in New Product Introductions.

AREAS OF EXPERTISE:

Quality Systems: QA, CAPA* Lean Manufacturing, Six Sigma

Principles: PPAP, PSW, IATF 16949 / AS9100, GD&T

New Product Introduction: Medical Device Manufacturing, GMP* Statistical Process Control, Cpk, Ppk Microsoft Office Expert, Excel, Minitab* Gage R&R

Tool: ing Qualification: SAP R/3 Implementation & Super User* ISO Internal Auditing, Compliance, ISO-9001,14000 Asset accounting, Asset Management

EXPERIENCE:

Confidential, Rochester, NY

Quality Engineer

Responsibilities:

• Responsible for manufacturing quality of automotive and aerospace parts as a Tier 2 supplier.
• Prepared PPAP packages for new parts & processes including PCP / PFMEA / FAIR under tight timelines.
• Responded to Customer issues / requests following 8D process.
• Qualified new tooling for automotive / aerospace parts.
• Prepared release specifications according to customer blueprints.

Confidential, Rochester, NY

Product Quality Data Analyst

Responsibilities:

• Monitored contact lens production data on 2 newly commissioned fully automated high speed contact lens production lines run under GMP.
• Created programs to track performance against various metrics daily and weekly.
• Analyzed Production and Validation protocol data using statistical analysis for trends and predictors of future performance.
• Reacted to Production performance deviations and performed root cause analysis.
• Created and monitored control charts of critical lens parameters, including injection molded part data, in-process data, and lens release data.

Confidential, Alden, NY

Quality Engineer

Responsibilities:

• Developed Product Specifications (Quality Control Plans) from Product Blueprints in conjunction with Development for new Medical Device Product Introductions.
• Member of the New Product Introduction Team. Ran Tooling Qualifications (Gage R&R studies, MSA’s) on new and modified tooling.
• Used statistical analysis (Minitab, etc) to calculate Ppk’s and Cpk’s on initial and improved Products and Processes, and identify trends.
• Handled day to day shop floor quality issues.
• Followed Change Management procedures under Medical Device Manufacturing Controlled processes

Confidential, Rochester, NY

Senior Manufacturing Quality / Process Engineer

Responsibilities:

• Tracked and analyzed Product Quality using testing methods: automatic laser analysis, CMM machine, surface roughness, surface hardness and gloss measurements.
• Calculate and maintain Cpk’s and Ppk’s monthly and quarterly.
• Troubleshoot and monitor daily Process Operations: Blade coating, liquid injection molding, CNC Lathe and Grinding, Fluoropolymer mixing, gravure coating of reactive solutions, and Clean room mixing and coating operations.
• Ran cross-functional team Process and Quality Improvement projects.
• Investigated and resolved supplier quality, internal quality and external customer complaints
• Used manufacturing best practices, Lean Manufacturing, 6 sigma initiatives, cost reduction projects and product recycling, resulting in increased product yields by 50%, increased topcoating product throughput by 25%, and reduced product UMC’s by 20%.
• Eliminated the use of a hazardous air pollutant chemical in the coating process of one of the products, reducing usage of this chemical on-site by 25%.
• In conjunction with Health & Safety applied for facility air emissions permits, allowing compliance with DEC regulations.
• Implemented “clean” filters on final coating baking ovens, reducing defects on final rollers by 20%.
• Installed a computer data entry system for final inspection of rollers; going to a paperless system eliminated operators writing the data on paper, and allowed automatic data extraction into Excel as needed/required.
• Redesigned product packaging that eliminated all shipping damage, resulting in significant $ savings

Confidential, Rochester, NY

Product Quality / Process Manufacturing Engineer:

Responsibilities:

• Responsible for maintaining Product Quality Plans (specifications).
• Tracked and analyzed product day to day quality and quarterly Cpk’s.
• Testing methods included TGA, GC/MS, % volatiles, etc. Made Bills of Material, Routing, etc. changes as required as required via the Change Management System.
• Monitored Toner Manufacturing Processes (melt compounding / extrusion, dry pulverizing, surface treatment, and packaging) and Developer Manufacturing Processes.
• Scaled-up and Commercialized toner and developer products from Product Development into Production (New Product Introduction).
• Maintained Supplier Quality relationships for several unique raw materials and packaging supplies.
• Lead a team to qualify product for and successfully bring on-line a European toner plant.
• Met with raw materials and parts suppliers and ensured product quality objectives and quality / cost improvements were met or exceeded.
• Lead teams to certified alternate Manufacturing plants for key raw materials, including one to Japan, without any stockouts or quality issues.