Medical Device Quality Engineer Resume

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Contact Number: (012)-345-6789

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Career Objective:

Individual with thorough experience about validation protocols, risk assessment and product development cycles of medical devices, intends to work as a medical device quality engineer for a leading organization.

Summary of Skills:

  • Comprehensive knowledge of product development life cycle, risk assessment, and validation protocols
  • Extensive knowledge of methods and process of medical device design control
  • In-depth knowledge of the concepts of engineering change control, statistical techniques, and IQ validation protocols
  • Well-versed in the methodologies of software validation and verification, sterilization processes, and FDA (21CFR 803/806/820)
  • Familiar with FDA Quality System Requirements/ISO 13485, Six Sigma, quality auditing, and engineering drafting
  • Sound knowledge of Solid Works, ISO (ISO: 13485) regulations, Gage R&R, and Pro Engineering concepts
  • Well-versed in communicating effectively with knowledge of basic computer applications
  • Hands-on experience in testing quality of medical devices for various applications with sound knowledge of standard quality testing

Work Experience:

Medical Device Quality Engineer
Eilliam Medical Equipment, Inc., Lilburn, GA
October 2014 – Present

  • Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance
  • Guiding quality assurance engineers in IQ/OQ/PQ activities and validation process
  • Planning and implementing quality testing procedures, scheduling project plans, and preparing documents
  • Generating techniques of quality-engineering to test medical devices
  • Handling customer queries and ensuring customer satisfaction by providing effective services
  • Executing validation activities as well as provide support to the staff to achieve project milestones

Junior Medical Device Quality Engineer
Pigeon Medical Services, Lilburn, GA
February 2013 – September 2014

  • Providing support to the senior medical device engineers in manufacturing and installing medical devices
  • Developed new processes for testing various parts of medical equipment and devices
  • Provided effective support in all the stages of product development by applying quality engineering applications
  • Assisted senior medical device engineers in creating test case strategies
  • Performed root causes analysis of failures in electrical and mechanical parts


  • Bachelor’s Degree in Electronics Engineering
    ABC University, Lilburn, GA


On request.