Dwan Marshall

Company Overview: Global manufacturing medical device development in RAS (Surgical Robotic devices-Single and Multiport)

• Provide QMS and regulatory compliance expert support cross functionally, to include CFR 820, ISO 13485 & GxP interpretation across BUs
• GxP Supplier/ Vendor program management, to include approved supplier qualification, audits, process controls and SCARs
• Monitoring performance dashboards
• Develop Quality Plans, Quality Agreements, Service Level Agreements and quality system procedures to ensure global compliance
• Regional QSM responsibilities included US, Japan, Taiwan, China joint ventures, India, Canada, and Brazil
• Revised and developed SOPs, DOPs & WIs via Change order routing
• Management of Nonconformance program process lifecycle management
• High-risk CAPA support and management (pre-inspection readiness activity and 483 core response team 2021 & 2022 and DNV findings response team 2022-2024)
• Support regulatory and notified body audit activities to include strategy, SME prep, audit requests management, and official audit closure
• Developed corrections and corrective action plans in response to internal and external non-conformances
• EUMDR Core team member with QP responsibilities- SLA implementation(s)
• eQMS advanced knowledge in Trackwise, Windchill, Agile and Veeva
• Travel
• Global manufacturing medical device development in RAS (Surgical Robotic devices-single and multiport)
• Train new employees on company policies and procedures, contributing to a cohesive team atmosphere and improved overall performance.
• Conduct regular reviews of operations and identified areas for improvement.

• Company Overview: Class I -MDDS-Medical device manufacturer of digital image communication systems
• Total quality systems management of QMS and operations quality
• Management Rep
• Draft and/or review approval of Complaints, NCRs, CAPAs, SCARs QPs Risk reviews, and CCOs
• Support internal inspections, supplier qualification audits, and third party QS evaluations, back room lead
• Knowledge of FDA, notified bodies, Health CA, and Australia TGA regulations and standards
• Management of the QA/ RA inputs and outputs and Key Submitter of eMDR filings
• Completed regulatory and certification filings domestic and international
• Managed technical files throughout product life cycles
• Development and management of supplier quality files and complaints management system implementation
• Lead team of 2 direct reports 1-Principle QE, 1-SQE
• Developed CAPA plans in response to internal and external non-conformances, audit observations, through adequate formal response to drive QP initiative
• Established the Change Control Review Board
• Reduced complaint rates by establishing classification and proper review, NCR, CAPA & SCAR back logs by 75%
• Standardization of SOPs
• Revised and implemented over 15 effective SOPs within 4 months
• Standardized DHF & DMR formats
• Class I -MDDS-Medical device manufacturer of digital image communication systems

Company Overview: Global Manufacturer of Class I & II medical devices and pharmaceuticals for both Domestic and International markets

• Principal QE/ QS Supervisor (Interim) with alternate Management Rep responsibilities leading a team of 5 direct reports: 2 Quality Engineers, 1 Validation Engineer, 1 CAPA Engineer and 1 QE Tech
• Facilitate global QS audits across division and audit support internal/ external response(s)
• CAPA and NC escalation SME, post market surveillance investigations, reviewer & advisor
• Leading risk reviews, RMF updates/ Change Control revisions and management of risk assessments related to product and process reviews
• Improved water utilities vendor relations and annual sanitization program resulting in 0 excursions of water quality over 6 consecutive monitoring.
• Travel 20%
• Accomplishments - Successful improvement of site level complaints investigation closure timeliness via Windchill system - Promoted to QS Supervisor Interim of Quality Engineering within 1st six months with organization. Principal engineer of Water Utilities, system design and maintenance. Lead system commissioning and validation process for new system qualification, implementation, and pricing $42k under budget
• Improved system efficiency by streamlining processes and implementing automation tools.
• Monitored system performance metrics regularly, identifying areas for optimization or upgrades when necessary.
• Enhanced data integrity through regular audits, backups, and adherence to best practices in data management.

Company Overview: Automotive manufacturer North American Headquarters

• Regional technical writer of quality policies and procedures for all North American manufacturing facilities and affiliates
• Liaised between Japan and US quality division drafters/ change management lead to develop global standards translated and transcribed into regional quality requirements for manufacturing operations
• Acting Global Special Committee member for North America
• Conduct quality audits & supplier recertifications across all North American manufacturing facilitates
• Manage North American regional eQR/QS (Quality requirements/standards/ handbooks) system
• Travel
• Accomplishments - Reduced past-due list of regional procedures pending approval and publication by 50% within 3 months
• Developed standardization of procedure publication process via SharePoint System; 30/60 back-log procedures revised and published for regional use within 4 months
• Automotive manufacturer North American Headquarters

• Company Overview: Contract Manufacturer of Class I, II, and unclassified medical devices, pharmaceuticals, and cosmetics for both Domestic and International markets
• Liaised between contract business entities, manufacturing and executive teams as principal engineer in technology transfers and qualifications for end products integrating into operations and consumer market
• Restructured the supplier quality program and audits
• Managed 3 direct reports, 1 Quality Engineer, 1 Doc Control Specialist and 1 Complaints Specialist
• Accomplishments- Coached and mentored Quality Associate, as a result promoted QA Associate to Associate Engineer
• Successfully established the Supplier Quality Management Program
• Promoted to Principal Engineer of Technology transfer a $4.5M Manufacturing Contract of a medical device product commercialization
• Principal Engineer for clinical trials projects
• Contract Manufacturer of Class I, II, and unclassified medical devices, pharmaceuticals, and cosmetics for both Domestic and International markets

• Managed federal and local regulatory and accreditation agency inspections and readiness activities
• Performed medical audits during surgery for Universal Protocols assurance
• Promoted twice within an 18 month timeframe, from Accreditation Clinical Abstractor to Regulatory Specialist, to Sr
• Regulatory Specialist

• Company Overview: Local Manufacturer of blood for transfusions and blood product(s) for research
• Performed analytical chemistry testing
• Local Manufacturer of blood for transfusions and blood product(s) for research