Principal Quality Engineer@ CareFusion
Escondido, California, United States
Erik Rodriguez
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National University
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FlashIntel GPTErik Rodriguez is a highly experienced quality system professional with over 22 years of work experience. He has expertise in medical devices, FDA regulations, validation, and ISO. Currently, he is working on 2 510(k) submissions and is responsible for obtaining clinical trial data. Erik has worked with reputable companies such as CareFusion, D&K Engineering, Global Regulatory Solutions, and Certified Compliance Solutions. He is a certified 13485 Lead Auditor and has successfully assisted with validation projects. Erik is based in Escondido, California.
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About
Very broad base and concentrated experiences with many aspects of quality system. Certified 13485 Lead Auditor. Experiences include: Worked on and assisted with over 150 individual validation projects. Created several quality systems from the ground up. Assisted in the resolution of several dozen 483 observations, Field Corrective Actions, and Recalls. Obtained clearance for 1 510(k). Assisted with several 510(k) submissions. Currently working on 2 510(k) submissions. Assisting with a PMA effort, which is currently obtaining clinical trial data. Specialties: Medical Device Validation ISO and QSR Audit Process Validation FDA Preparation 510(k) Submissions
...See MoreWork Experience
Principal Quality Engineer
Senior Engineer, Quality
Medical Equipment Manufacturing
Erik Rodriguez's Professional Milestones
- Senior Software Quality Engineer (2004-09-01~2010-06-01): Implementing robust testing strategies to drive software excellence and mitigate defects.
- Principal Quality Engineer (2016-06-01~): Implemented robust quality control measures to optimize product performance and customer satisfaction.
Education
Business Administration,
Management,
Business Administration And Management,
Bachelors,
Bachelor Of Science
2008-2016Skill
Quality System
Medical Devices
Fda
Validation
Iso
Software Documentation
Quality Control
Iso 13485
Capa
Design Control
Auditing
Iso 14971
Management
Certification
Colleagues
Kieran Gallahue
Chairman | Chief Executive Officer
karla vargas
Chief Executive Officer
Mattie Case
Executive Administrative Assistant To Segment Coordinator | Procedural Solutions
CFNBD Admin
Chief Information Officer
Stephen Lewis
Chief Medical Officer
Other Named Erik Rodriguez
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Erik Rodriguez works for CareFusion
Erik Rodriguez's role in CareFusion is Principal Quality Engineer
Erik Rodriguez works in the industry of Medical Equipment Manufacturing
Erik Rodriguez's colleagues are Kieran Gallahue,karla vargas,Mattie Case
Erik Rodriguez's latest job experience is Principal Quality Engineer at CareFusion
Erik Rodriguez's latest education in National University
