Manufacturing Quality Engineer Resume

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Manufacturing Quality Engineer Resume

Rodriguez Taylor
P.O. Box 47
Chicago, IL 60601
Fax 45-76-89-23

Objective

To work in Challenging demanding all my skill and efforts to explore and adapt myself in different field, and realize my potential and contribute to the development of organization with impressive performance.

Experience

Manufacturing Quality Engineer
St. Jude Medical - Minnetonka, MN

  • Developed, implemented and supported on-going production processes, methods, tools, equipment, and controls for the manufacture of products and components consistent with obtaining and maintaining design integrity, optimum costs, quality, inventories, and investment in facilities.
  • Provided leadership and sets direction for a small team of manufacturing engineers, processing technicians and maintenance personnel.
  • Actively applied new manufacturing technologies and aggressively evaluates and reported on manufacturing opportunities which will contribute to the plant’s objectives and goals.
  • Participated in Kaizen improvement activities to assure optimum productivity and costs. Suggests alternative designs, materials, or processes. Must be capable of resolving all problems while maintaining good rapport with customers and peers.
  • Maintained effective communications with all people affected by projects and issues operating instructions when required. Issues periodic status reports to keep affected personnel informed.
  • Prepared manufacturing studies to determine optimum manufacturing costs, quality, and inventories and/or evaluates feasibility for new or existing products, processes or materials.
  • Recommended changes for the most practical and economical manufacturing processes, including material, labor, tooling, equipment, and ancillary factors.
  • Participated in selecting, approving, and developing tooling and equipment to satisfy manufacturing requirements and product design intent.

Quality Engineer
Becton Dickinson - Durham, NC

  • Provided product team support including customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
  • Assisted with the investigation of Corrective/Preventive Actions (CAPA), notifications and customer complaints, providing solutions where possible. Communicates customer feedback to Quality Systems group.
  • Applied quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol Development or Review and Approval, Control Plans
  • Supported Continuous Improvement activities.
  • Developed Quality Plans including: incoming, in-process and final inspection, providing training to those affected by the plans.
  • Implemented proven inspection and metrology improvements and associated training.
  • Reviewed and Approved Project Design History File review/approval.
  • Created technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO.
  • Served as a resource for performing internal audits to assure quality system compliance.

Education

  • Bachelor’s degree in Engineering, Adelphi University (NY)

Skills

  • Experience in a quality assurance role within a manufacturing environment.
  • Produced and processed validation experience.
  • Polished communicator- written documentation and oral presentations/ discussions/ meetings
  • Excellent reputation for building relationships
  • Organized, on-time, and detailed project management skills
  • Energized attitude
  • Preferred Qualifications
  • Medical device background preferred.
  • ASQ CQE preferred.
  • Small company, start up experience is appreciated in this role
  • Knowledge of statistical methods for quality assurance, i.e. capable of Six-Sigma skills, certification preferred.
  • Knowledge of the regulatory industry requirements ISO9001: 2000, ISO13485, and Quality Systems Regulation CFR 21 part 820.
  • Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.

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