LYN MAPLES
Raleigh,NC
Summary
Quality and operations professional with expertise in supplier quality inspection and regulatory compliance in medical device and pharmaceutical industries. Successfully led continuous improvement initiatives and addressed nonconformance issues using SAP and Power BI for enhanced data analysis. Achieved measurable performance improvements through proactive team engagement on the shop floor and in the warehouse.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Quality Engineer II / Supplier Quality Engineer II / Incoming Materials Manager
Becton Dickinson
Sumter, SC
06.2025 - Current
- Spearheaded investigation into push button blood collection system gripper failures, utilizing FMEA and root cause analysis to reduce complaints by 75%.
- Reduced supplier quality notifications by 50% in 7 months through development of targeted scorecards and improved accountability.
- Directed cross-functional team of 8+ quality professionals to optimize labor allocation, enhancing inspection coverage and production efficiency.
- Implemented corrective actions to resolve non-conformance issues, enhancing compliance and quality assurance.
- Led global initiatives standardizing quality notification documentation to improve audit readiness and consistency across sites.
- Orchestrated recovery project closing over 600 aging quality notifications, restoring compliance and responsiveness.
- Drove quarantine and containment strategies for nonconforming materials, achieving traceability across multiple value streams.
- Conducted comprehensive supplier audits to ensure adherence to FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
CEO / Co-Founder
The M2B Group, LLC
Mt. Pleasant, SC
06.2019 - 06.2025
- Architected and deployed comprehensive quality management systems (QMS) using Qualio, ensuring adherence to ISO and FDA requirements.
- Led process improvement initiatives for international clients, advancing compliance and operational performance.
- Implemented GMP documentation programs, enhancing operational efficiency across diverse client portfolios.
- Consulted on quality regulations and QMS for manufacturing clients, enhancing compliance and operational standards.
- Facilitated audit readiness for companies, ensuring adherence to regulatory compliance standards.
Quality Specialist
Thorne Nutraceutical
Summerville, SC
01.2022 - 02.2023
- Led internal audits and CAPA meetings, overseeing ETQ documentation and driving quality improvement.
- Managed supplier audits and qualification programs to ensure adherence to quality standards.
- Conducted root cause analysis and executed corrective actions for quality enhancements.
- Coordinated cross-functional efforts to address quality issues and optimize processes.
- Developed cGMP training programs that enhanced compliance across departments.
- Implemented risk-based internal audit programs to improve compliance and efficiency.
- Established strong relationships with external manufacturers and internal teams.
- Facilitated supplier communication to maintain compliance with regulatory standards.
Director of Business Development and Quality
Rymedi
Greenville, SC
06.2019 - 07.2020
- Managed implementation of blockchain technology and quality management system at three large distribution centers in Kenya, enhancing compliance and operational efficiency.
- Developed compliance documentation and quality processes, ensuring adherence to regulatory requirements and minimizing risk exposure.
- Developed quality management system for blockchain-based supply chain platform to enhance operational standards.
- Facilitated initiatives for supply chain security and regulatory compliance, strengthening operational integrity.
- Collaborated on FDA blockchain pilot related to DSCSA compliance.
Global Learning & Development / Document Control / QMS Coordinator
GSK-JSG
Raleigh, NC
08.2016 - 06.2019
- Develop and Maintain QMS: Implement and maintain the Quality Management System in line with organizational objectives and industry standards, ensuring compliance with regulations such as ISO 9001.
- Managed document control and training documentation, ensuring compliance with regulatory requirements in manufacturing environment.
- Management Reviews: Organize and lead Management Review meetings to evaluate QMS performance and identify opportunities for improvement.
- Trained and coached staff on QMS policies and procedures, fostering a culture of quality throughout organization.
- Planned and conducted internal audits to evaluate QMS effectiveness, identify improvement areas, and ensure regulatory compliance.
- Performed audits to assess compliance with regulatory standards to ensure compliance with regulatory standards.
- Created technical documentation to support compliance with industry regulations.
- Assisted in remediation projects, improving compliance with regulations and mitigating risk.
- Documented and reported non-conformances and corrective actions, monitoring resolution to uphold compliance with quality standards.
Operations Support Coordinator
Michelin North America
Greenville, SC
06.2010 - 06.2015
- Coordinated inventory and logistics to ensure on-time delivery of materials.
- Supported manufacturing operations, enhancing supply chain and distribution efficiency.
- Resolved operational issues alongside production teams, engineering, and logistics.
- Streamlined workflows through process improvements in CRM platform to enhance user experience.
- Generated performance reports to inform decision-making and optimize processes.
- Ensured compliance with safety and quality standards in production processes.
- Monitored regulatory changes in automotive laws to maintain up-to-date compliance policies.
- Implemented Tyrecheck system for transit and trucking industries, collaborating with internal teams to optimize operational efficiency.
Education
Bachelor of Arts - undefined
Clemson University
Skills
- Supplier quality management
- Quality control and inspection
- Manufacturing operations leadership
- Quality management systems
- CAPA
- SCAR
- RCA
- FDA
- GMP
- Regulatory compliance
- Internal and supplier audits
- Material review board participation
- Nonconformance management
- Continuous improvement strategies
- Change control processes
- SAP
- Apriso
- TrackWise
- Power BI
- Pega
- Aravo
- Process improvement initiatives
- Digitized legacy manual record-keeping
- MasterControl EBR system
- GMP documentation practices
- Patent development
Websites
Certification
Preventive Controls Qualified Individual (PCQI)
Timeline
Quality Engineer II / Supplier Quality Engineer II / Incoming Materials Manager
Becton Dickinson
06.2025 - Current
Quality Specialist
Thorne Nutraceutical
01.2022 - 02.2023
CEO / Co-Founder
The M2B Group, LLC
06.2019 - 06.2025
Director of Business Development and Quality
Rymedi
06.2019 - 07.2020
Global Learning & Development / Document Control / QMS Coordinator
GSK-JSG
08.2016 - 06.2019
Operations Support Coordinator
Michelin North America
06.2010 - 06.2015
Bachelor of Arts - undefined
Clemson University