Rod Mell Email & Phone Number
Executive Head - Medical Device Consulting @ Regulatory Compliance Associates (RCA)
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Rod Mell Location
- Pleasant Prairie, WI, US
Rod Mell Work
- Executive Head - Medical Device Consulting @ (January 2023 - Present)
- Head of Quality and Regulatory @ (August 2017 - July 2022)
- Vice President Quality @ (April 2015 - August 2017)
- Sr. Quality Director @ Baxter International Inc. (April 2013 - April 2015)
- Quality Director - New Product Development @ Baxter Healthcare (January 2009 - March 2013)
Rod Mell Education
- University of Missouri-Rolla
BS (Electrical Engineering - Emphasis on Controls)
1990-1993
Rod Mell Skills
- ISO 13485
- FDA
- Medical Devices
- Quality System
- CAPA
- Change Control
- Product Launch
- ISO 14971
- 21 CFR
- GMP
- Quality Assurance
- Product Development
- Design Control
- Sop
- DMAIC
- Computer System Validation
- Regulatory Submissions
- FDA GMP
- Cross-functional Team Leadership
- CE marking
- Biomedical Engineering
- Calibration
- Manufacturing
- Complaint Management
- Manufacturing Operations
- Design of Experiments
- Aseptic Processing
- 21 CFR Part 11
- Corrective and Preventive Action (CAPA)
- Cleaning Validation
- Biotechnology
- Biopharmaceuticals
- Leadership
- Sales
- Process Improvement
- Strategic Planning
- Cross Functional Team Leadership
- Product Management
- Corrective and Preventive Action Capa
- Corrective and Preventive Action
Rod Mell Summary
- Rod Mell, based in Pleasant Prairie, WI, US, is currently a Executive Head - Medical Device Consulting at Regulatory Compliance Associates (RCA). Rod Mell brings experience from previous roles at Philips, Alere Inc., Baxter International Inc. and Baxter Healthcare. Rod Mell holds a 1990 - 1993 BS in Electrical Engineering - Emphasis on Controls @ University of Missouri-Rolla. With a robust skill set that includes ISO 13485, FDA, Medical Devices, Quality System, CAPA and more. Rod Mell has 2 emails and 2 mobile phone numbers on RocketReach.
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