LYN MAPLES
Raleigh,NC
Summary
Results-oriented Quality Engineer with strong expertise in supplier quality inspection and regulatory compliance in medical devices and pharmaceuticals. Led cross-functional teams to implement CAPA processes and drive continuous improvement initiatives. Leveraged SAP and Power BI to enhance data analysis and operational efficiency, significantly improving performance and compliance.
Overview
1
1
Certification
16
16
years of professional experience
Work History
Quality Engineer II / Supplier Quality Engineer II / Incoming Materials Manager
Becton Dickinson
Sumter, SC
06.2025 - Current
- Led team of 6–8 direct reports in incoming inspection and supplier quality functions.
- Managed incoming inspection quality control and material release processes to ensure timely production support.
- Acted as a material review board member, resolving nonconforming material issues.
- Oversaw approved supplier list and performance metrics, driving accountability through scorecards and corrective actions.
- Issued and managed supplier corrective action reports to ensure resolution of nonconformances and prevent recurrence.
- Conducted root cause investigations for defects and customer complaints to drive improvements.
- Performed supplier audits and managed assessment schedules for compliance verification.
- Collaborated with new product development teams to qualify suppliers and components.
CEO / Co-Founder
The M2B Group, LLC
Mt. Pleasant, SC
06.2019 - 06.2025
- Consulted on quality regulations and QMS for manufacturing clients to enhance compliance and operational standards.
- Implemented quality management systems and GMP documentation programs, streamlining compliance processes.
- Developed SOPs, validation documentation, and regulatory documents to ensure adherence.
- Trained personnel on GMP documentation practices and quality systems to improve knowledge retention.
- Led engineering teams in equipment installation and validation activities, including IQ, OQ, and PQ.
- Directed process improvement initiatives for international clients, resulting in improved compliance and enhanced operational performance.
- Supported companies in achieving audit readiness while maintaining regulatory compliance.
- Assisted team in developing patent for machine innovation in renewable energy, contributing to industry advancements.
Quality Specialist
Thorne Nutraceutical
Summerville, SC
01.2022 - 02.2023
- Implemented risk-based internal audit programs to improve compliance and operational efficiency.
- Conducted internal audits and CAPA meetings, managing documentation to ensure compliance and quality standards.
- Oversaw supplier audits and qualification programs to ensure quality standards adherence.
- Developed CGMP training programs to enhance compliance across departments.
- Coordinated cross-functional teams to resolve quality issues and streamline processes.
- Established collaborative relationships with external manufacturers and internal stakeholders to enhance quality assurance processes.
- Performed root cause analysis and executed corrective actions for quality improvements.
- Facilitated supplier communication, ensuring adherence to regulatory standards and fostering compliance.
Director of Business Development and Quality
Rymedi
Greenville, SC
06.2019 - 07.2020
- Facilitated supply chain security and regulatory compliance initiatives, improving operational integrity.
- Created compliance documentation and quality processes to ensure regulatory adherence.
- Collaborated on FDA blockchain pilot for DSCSA compliance, strengthening regulatory framework.
- Led development of Quality Management System for blockchain-based supply chain platform.
- Managed implementation of blockchain technology and quality management system in Kenya, optimizing operations for 3 large distribution centers.
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 and alignment with regulatory requirements in manufacturing environment.
- Training and Coaching: Train and coach staff on QMS policies and procedures to foster a culture of quality throughout the organization.
- Planned and conducted internal audits to evaluate QMS effectiveness, identify improvement areas, and ensure regulatory compliance.
- Conducted audits to ensure compliance with regulatory standards.
- Created technical documentation to support compliance with industry regulations.
- Assisted in remediation projects to enhance compliance with regulations.
- Management Reviews: Organize and lead Management Review meetings to evaluate QMS performance and identify opportunities for improvement.
- Documented and reported non-conformances and corrective actions, monitoring resolution to maintain compliance with quality standards.
Operations Support Coordinator
Michelin North America
Greenville, SC
06.2010 - 06.2015
- Coordinated inventory and logistics to ensure timely delivery of resources.
- Supported manufacturing operations and supply chain processes, contributing to overall efficiency improvements.
- Improved operational workflows through process enhancements in CRM platform.
- Generated performance reports to guide decision-making and streamline operational processes.
- Assisted production, engineering, and logistics teams in resolving operational issues, facilitating smoother operations.
- Identified and resolved bottlenecks impacting production timelines effectively.
- Implemented TyreCheck system for transit and trucking industries with internal team collaboration.
- Ensured compliance with production safety and quality standards across operations.
Education
Bachelor of Arts -
Clemson University
Clemson, SCSkills
- Supplier quality management
- Quality control
- Quality systems
- CAPA and RCA
- Regulatory compliance
- Supplier audits
- Nonconformance management
- Manufacturing operations leadership
- Continuous improvement
- Process improvement
- Change control
- SAP expertise
- Power BI proficiency
- PEGA knowledge
- Material review board participation
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 -
Clemson University