Medical Device Quality Engineer Resume

George Smith

1556 Gambler Lane

Houston, TX 77028



Job Objective Seeking work as a Medical Device Quality Engineer in which to exercise my past experience in the field for the good of the company.

Summary of Qualifications:

  • Vast experience in medical, mechanical device production, test, and inspection
  • Skilled to oversee manufacturing of electrical medical devices
  • Deep knowledge of FDA Medical Device Reporting and international medical device regulations
  • Huge knowledge of cGMP and ISO standards of medical and pharmaceutical devices
  • Immense ability to develop and document validating protocols
  • Good understanding of ISO 9001: 2008, FDA 21CFR820, ISO 13485 PAP, QFD, CtQ breakdown, DfSS, SPC, AQP, FMEA and Control Plan
  • Proficient with C/C++, LabView/MatLab, Failure Modes Effect Analysis (FMEA), GD&T, SPC, Root Cause Analysis, and Mistake Proofing

Work Experience:

Medical Device Quality Engineer, August 2005 – Present

Avantec Vascular, Houston, TX

  • Monitored facility and implemented Quality systems for products in accordance to cGMP and ISO standards.
  • Managed all engineering problems of facility.
  • Determined validation program for process and product in compliance with required protocols.
  • Ensured that Quality Assurance standards were maintained throughout product life cycle.
  • Inspected design and manufacturing facility and performed root cause analysis.
  • Trained junior staff department in implementations of various quality tools and procedures.
  • Documented process and prepared reports to be presented in technical presentations.
  • Provided technical support to CAPA and resolved all quality issues.

Medical Device Quality Engineer, May 2000 – July 2005

Coyote Technical & Executive Sourcing, Houston, TX

  • Inspected facility and performed root cause analysis and recommended corrective actions for same.
  • Analyzed process and products and implemented enhanced quality systems to processes such as six sigma and 5S.
  • Coordinated with operations department and ensured that new products were produced in accordance to procedures.
  • Ensured that all corrective and preventative actions were taken in required timeline.
  • Prepared test methods and protocols for product development team and designed fixtures.
  • Coordinate with Regulatory affairs and ensured that all documents were maintained in accordance to FDA regulation.


Bachelor’s Degree in Mechanical Engineering, Austin College, Sherman, TX

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  • March 1, 2020Create Date
  • March 1, 2020Last Updated

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