Charles Young
Buford,GA
Summary
Results-driven quality management professional with over 25 years of experience, including 15 years in the medical device industry. With a proven track record at Johnson & Johnson, driving Lean Six Sigma initiatives that saved $1.6 million. Adept at leading global teams, managing external audits, and driving continuous improvement initiatives.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Staff Quality Engineer
Johnson & Johnson - Ethicon
Cornelia, GA
07.2015 - 01.2026
- Led a Lean Six Sigma initiative to decrease scrap needles, resulting in annual savings of $32,000.
- Led test method validations for new products, ensuring compliance and quality.
- Led preventative and corrective action (CAPA) for key manufacturing processes.
- Led equipment process validation, including IQ, OQ, and Performance Qualification (PQ).
Quality Assurance Manager
Avantor
Buford, GA
02.2024 - 03.2025
- Implemented corrective and preventive action (CAPA) systems, significantly reducing defect rates and improving product reliability.
- Supervised and guided inspectors, engineers, and other staff.
- Directed the creation and upkeep of QMS for constant enhancement and effectiveness.
- Directed the preparation and execution of internal and external audits, achieving compliance with ISO standards and other regulatory bodies.
Quality Acquisition & Divestiture Project Manager
Johnson & Johnson - Cerenovus Stroke Solutions
Remote
10.2023 - 02.2024
- Developed and executed quality work plans to transfer QMS elements to the acquiring company.
- Led cross-functional teams (Quality, Distribution, Supplier Quality, IT, and Marketing) to align QMS requirements.
- Ensured compliance by transferring Management Review records, high-risk CAPAs, and quality performance metrics.
- Provided training to the new business unit on QMS processes and regulatory expectations.
Quality Program Manager
Johnson & Johnson - DePuy Mitek, Inc
Remote
10.2021 - 07.2023
- Led a team of design quality engineers to update technical files for over 2,000 SKUs, achieving compliance with MDSAP, 21 CFR Part 820, and EU MDR.
- Ensured all technical files met ISO 13485:2016 and ISO 14971 compliance requirements.
- Led regulatory compliance efforts, including design controls, risk analysis, and post-market surveillance.
- Led design quality in audits and implemented technical documentation improvements.
Franchise Quality Engineer Manager
Johnson & Johnson - Ethicon
Cornelia, GA
01.2016 - 10.2021
- Led multi-site initiatives, achieving $1.6M in cost savings through process improvements and best practices.
- Supervised a global team in executing risk management strategies, statistical applications, and ensuring compliance.
- Led deep-dive reviews of adverse events, complaint aging, and CAPA effectiveness at Management Review Boards.
- Owned the statistical application compliance program, ensuring proper validation, and trend analysis.
- Tracked key performance indicators (KPI) using Oracle Instantis PPM software for multi-site quality oversight.
Senior Quality Engineer
Medtronic Powered Surgical Solutions
Fort Worth, TX
05.2010 - 07.2015
- Implemented networked micrometers and calipers with InfinityQS SPC to reduce variability and improve accuracy.
- Conducted Gauge R&R studies, identifying measurement inconsistencies, and retraining inspectors to improve precision.
- Led CAPA investigations and implemented corrective actions using structured methodologies (8D, A3).
- Supported R&D with new product development, legacy product validation, and manufacturing process enhancements.
Education
Bachelor of Science - Electrical Engineer
Kettering University
Flint, MIAssociate of Science - Industrial Electronics
Lake Michigan College
Benton Harbor, MISkills
- Strategic Quality Oversight
- Lean Six Sigma
- Project & Program Management
- Process validation (IQ/OQ/PQ)
- Statistical analysis
- Regulatory Compliance Expertise: FDA 21 CFR Part 820
- ISO 13485 Compliance Management
- CAPA and Root Cause Analysis (8D, A3, 7-Step)
- ISO 14971 Risk Management
Certification
- Lean Six Sigma Black Belt
- Regulatory Compliance Expertise (21 CFR Part 820, ISO 13485, ISO 14971, EU MDR)
Languages
English
Native/ Bilingual
Accomplishments
- ENCORE Award (Ethicon) – Recognized for exceptional Quality Engineering support
- Service Impact Awards (Medtronic) – For driving quality initiatives and operational improvements
- Leadership Recognition (Medtronic) – Founded the first Employee Resource Group
- Completed 'Fit for a Cure 5K' walk/run (Ethicon)
Affiliations
- Member of Toastmasters International at Medtronic
- Served as Communication Officer for the Employee Resource Group (CERG) at Medtronic
Timeline
Quality Assurance Manager
Avantor
02.2024 - 03.2025
Quality Acquisition & Divestiture Project Manager
Johnson & Johnson - Cerenovus Stroke Solutions
10.2023 - 02.2024
Quality Program Manager
Johnson & Johnson - DePuy Mitek, Inc
10.2021 - 07.2023
Franchise Quality Engineer Manager
Johnson & Johnson - Ethicon
01.2016 - 10.2021
Staff Quality Engineer
Johnson & Johnson - Ethicon
07.2015 - 01.2026
Senior Quality Engineer
Medtronic Powered Surgical Solutions
05.2010 - 07.2015
Bachelor of Science - Electrical Engineer
Kettering University
Associate of Science - Industrial Electronics
Lake Michigan College
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