Quality Engineer Resume
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Rochester, NY
SUMMARY:
- me is 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. me 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 teh company from management to shop floor.
- me 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 Principles
- 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 with Development for new Medical Device Product Introductions.
- Member of teh 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 teh use of a hazardous air pollutant chemical in teh coating process of one of teh 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 teh 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 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.
