Medical Device Quality Engineer Resume
Here is the Medical Device Quality Engineer Resume example:
George Smith
1556 Gambler Lane
Houston, TX 77028
(555)-555-5555
[email]
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.
Education
Bachelor’s Degree in Mechanical Engineering, Austin College, Sherman, TX
Medical Device Quality Engineer Resume
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- March 1, 2024Create Date
- March 1, 2024Last Updated
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