Rob Johnson
Principal Consultant at Independent Consultant for Quality & Regulatory | Norton Center, Massachusetts, United States
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Rob Johnson is an accomplished quality and regulatory professional currently serving as Principal Consultant at Independent Consultant for Quality & Regulatory. With a robust background in diverse manufacturing environments, Rob brings a wealth of practical knowledge and expertise to his role. His extensive experience in navigating the design control process and leading quality teams positions him as a trusted advisor for companies aiming to enhance their quality management systems (QMS) while mitigating regulatory risks.
In his current role, Rob is instrumental in conducting comprehensive QMS audits, performing gap analyses, and facilitating remediation efforts to ensure compliance with FDA Quality System Regulations (QSR) and ISO 13485 standards. His keen eye for detail and commitment to quality have made him a sought-after interim Director of Operations for Quality Assurance and Regulatory Affairs (QA/RA), where he effectively oversees critical projects such as technical file reviews and risk management file integrations. Rob's expertise in validation management and documentation, particularly in areas like device sterilization, cleaning, and biocompatibility, underscores his capability to support clients through complex regulatory landscapes.
Rob is particularly passionate about fostering a culture of continuous improvement within organizations. He believes that by integrating robust supplier management practices and emphasizing change management, companies can not only meet compliance requirements but also enhance their overall operational efficiency. His skills in software quality assurance and quality engineering further enable him to deliver tailored solutions that align with industry best practices. Through his strategic insights and hands-on approach, Rob Johnson is dedicated to helping organizations achieve their goals while navigating the intricacies of quality and regulatory compliance.
Principal Consultant at Independent Consultant for Quality & Regulatory in January 2015 to Present
Director of Quality at Symmetry Medical in September 2010 to January 2015
Quality Manager at MAKO Surgical Corp. in September 2005 to September 2010
Quality Manager, NPD at GMP Companies in May 2003 to September 2005
Staff Quality Engineer at Cordis in September 2000 to May 2003
Sr Quality Engineer at Ethicon Endo-Surgery in September 1997 to September 2000
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Quality Management
Medical Devices
Design Control
CAPA
Risk Management
Software Quality Assurance
Change Management
FMEA
Biocompatibility
Quality Auditing
Quality Systems Design
Clinical Evaluation
Sterilization
Design Verification Testing
Design Validation
Quality Engineering
Process Improvement
Process Validation
FDA GMP
Personnel Management
Regulatory Submissions
Regulatory Requirements
Supplier Quality
Quality Control
Reliability
Quality System
Six Sigma
ISO 13485
FDA
U.S. Food and Drug Administration (FDA)
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What is Rob Johnson email address?
Email Rob Johnson at [email protected]. This email is the most updated Rob Johnson email found in 2026.
How to contact Rob Johnson?
To contact Rob Johnson send an email to [email protected]. (updated on October 29, 2024)
What company does Rob Johnson work for?
Rob Johnson works for Independent Consultant for Quality & Regulatory
What is Rob Johnson's role at Independent Consultant for Quality & Regulatory?
Rob Johnson is Principal Consultant
What is Rob Johnson's Phone Number?
Rob Johnson's phone (413) ***-*184
What industry does Rob Johnson work in?
Rob Johnson works in the Medical Equipment Manufacturing industry.
Rob Johnson Email Addresses
Rob Johnson Phone Numbers
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