Medical Device Quality Engineer Resume

When writing a Medical Device Quality Engineer Resume remember to include your relevant work history and skills according to the job you are applying for. Whether you're seeking an entry-level position or have been in your career for a few years, exposing your relevant achievements in your resume can allow you to stand out and get that job interview.

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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