Devin McElroy

Background

About Devin McElroy

I have 20+ years hands-on experience in the medical device industry working as a Quality Management System expert for all device classifications. I have earned numerous professional certifications in QMS, Process Improvement, and Management areas. I have built Quality Management Systems from the ground-up for start-ups and have implemented Quality Improvement Programs for Fortune 500 companies with multinational footprints. Quality Management Systems | Process Improvements devin@dmcelroy.com | 925-353-0042 I will add significant breadth and depth of expertise in improving Quality Systems to more effectively comply with worldwide regulations and standards. I can significantly reduce your risk for receiving nonconformances from regulatory agencies and streamline remediation processes to eliminate repeat findings. Core Competencies - Technical Expertise: Integrates functional expertise with business knowledge to develop optimal solutions for the enterprise- Building and Leading Teams: Designs and implements workforce planning strategies to ensure a pipeline of talent over the long term and leverages understanding of strengths and weaknesses of team members in positioning them in the team- Maintains a Customer Focus: Establishes monitoring systems and practices to systematically gauge customer satisfaction- Collaboration and Teamwork: Advances positions that support the long term strategic interests of all stakeholders- Decision Making: Establishes decision-making processes that are appropriate given the complexity, risks, and impact of decisions and their urgency and/or importance. Greatest Achievements - Initiated error proofing initiative that resulted in a 80% reduction in manufacturing rejects and saved annually- Initiated a change control initiative that reduced engineering changes from 1203 minutes to 672 minutes (a 56% improvement in turn-around-time) while maintaining resource levels. I also earned my Six Sigma Green Belt from this initiative. Contact Devin at devin@dmcelroy.com or 925-353-0042 if you are looking for a QMS expert specializing in the medical device industry.