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Quality Engineer Resume

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Rochester, NY

SUMMARY:

  • I am a detail oriented Quality Engineer, Process Engineer, and Manufacturing Engineer wif 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 wif 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.

TECHNICAL SKILLS

  • Quality Systems, QA, CAPA
  • Lean Manufacturing, Six Sigma Principals
  • PPAP, PSW, IATF 16949 / AS9100, GD&T
  • New Product Introduction
  • Medical Device Manufacturing, GM
  • Statistical Process Control, Cpk, Ppk
  • Microsoft Office Expert, Excel, Minitab
  • Gage R&R, Tooling Qualification
  • SAP R/3 Implementation & Super User
  • ISO Internal Auditing, Compliance, ISO-9001,14000
  • Asset accounting, Asset Management* 2 US patents

PROFESSIONAL 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 (GD&T).

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 II

Responsibilities:

  • Developed Product Specifications (Quality Control Plans) from Product Blueprints in conjunction wif 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

Roller Manufacturing Department

Responsibilities:

  • 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 dis chemical on-site by 25%.
  • In conjunction wif Health & Safety applied for facility air emissions permits, allowing compliance wif 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:

  • Lead a team to qualify product for and successfully bring on-line a European toner plant.
  • Met wif 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, wifout any stockouts or quality issues.

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