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Quality Engineer Resume

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Rochester, NY

SUMMARY:

Productive and efficient Quality Professional. Experienced in adapting and developing quality systems at both small companies and international corporations. Able to create and automate tools to maximize benefits of the quality organization. Very good at making order out of chaos.

SKILLS AND ABILITIES:

Quality Systems & Processs Documentation: ISO - 9000, QS-9000, TS-16949, ISO-13485, IEC-60601, 21CFR820, APQP, PPAP, Control Plans, Process Flow, FMEA, Internal Audits, Product / Process Launch, Software and Hardware Verification & Validation, 21CFR11, CAPA, Policies, Device History File, Procedures, Work Instructions, Job Aids & Guidance Documents

Problem Solving & Process Control: Design of Experiments, Taguchi, Fast Response, Shainin, Regression, Pre-Control, SPC, Sample Plans, Error-Proofing, Gages & Fixtures, Six Sigma

Computers, Data Analysis, Processing & Automation: MS Office, Word, Excel, Access, Appli-cation Development, VB.Net, C#.Net, PowerPoint, Minitab, Database Design, Analysis Reports, Knowledge Base, C++, Javascript, ColdFusion, MySQL, HTML, CSS, PHP

Customer Relations: Complaint Resolution & Reporting, 8D Reporting (GM), PPAP Submission, Coordinating Customer Audits, 5P Analysis & Reporting (Honda)

Leadership & Management: Scheduling, Prioritizing, Performance Coaching, Direct Supervision, Task Oriented Training, Asset Acquisition & Planning, Job Descriptions, New Hire Interviews, Quality Concept Training, Career Coaching, Employee Evaluations

PROFESSIONAL EXPERIENCE:

Confidential, Rochester, NY

Quality Engineer

Responsibilities:

  • Created automation tools, for Process Qualification Reports, improving QE productivity.
  • Prepared and submitted customer PPAPs, in order to allow unrestricted shipping.

Confidential, Wyoming, NY

Quality Engineer

Responsibilities:

  • Implemented PreControl, in production, improving customer satisfaction.
  • Replaced 100% test, on key product, with sampling, saving one head-count for production

Confidential, Rochester, NY

Contract Quality Engineer

Responsibilities:

  • Audited production to prepare for customer’s line validation and allow unrestricted shipping
  • Developed production quality performance metric reports to help identify trends and issues.

Confidential, Medina, NY

Contract Product Quality & Validation Engineer

Responsibilities:

  • Led documentation verification team, helping assure readiness of new product version.
  • Assisted creation of Design History File, needed for regulatory approval of upgraded product.

Confidential, Rochester, NY

Continuous Improvement Manager

Responsibilities:

  • Implemented PreControl, in ring mills, reducing fallout, by 60%, in main production areas.
  • Created Quality Planning docs (FMEA, PCP), for all wk ctrs, improving CAPA response.

Confidential, Rochester, NY

Contract Quality and Validations Engineer

Responsibilities:

  • Worked DOE series & found process change, more than doubling yield on critical product.
  • Made new PPAP instructions, so non-experts could submit correct process approval requests.

Confidential, Auburn, NY

Process Quality Engineering Leader

Responsibilities:

  • Led Six Sigma project, cutting scrap 88% in target area, saving $750,000 / year.
  • Created Knowledge Base to improve consistency resolving quality issues.
  • Wrote web apps, to track test rejects and improve diagnostic abilities and response time.
  • Created app to identify short downtimes, allow better monitoring and improve productivity.

Confidential, Rochester, NY

Production Quality Engineer

Responsibilities:

  • Led multiple projects, reducing scrap fm $50,000 per month to under $10,000, in 2-1/2 years.
  • Wrote Application, to create and revise SPC Charts, reducing chart revision time by 85%.
  • Led engineering team to improve error proofing and reduce customer complaints by 60%.
  • Wrote SPC Reaction Guide, chosen as plant wide standard, improving QS9000 compliance.

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