Greater Minneapolis-St. Paul Area
Experienced: MedDev, Labeling, Quality, Continuous Improvement, People/Project Leader (PMP) Driven to Optimize: Simplified solutions / processes / systems which enable organizational success Leadership: Setting Goals, Communicating Vision, Fostering Collaboration/Creativity, Exhibiting Values Automation Champion, Power Software User: Collaboration, Enterprise (ERP), Product Lifecycle (PLM), Microsoft (Office, Visio, Project, Access, Power Platform), Content Management, Analytics (Minitab, MATLAB, Power BI), Labeling/Quality/Regulatory Data/Docs
Leader of Support/Analyst/Development team focused on Labeling, UDI, MDM System Development and Operations. Application ownership and Software Development Lifecycle responsibility in these areas. Accountable for maintaining collaborative relationships ensuring robust system implementation, business process success, and efficient compliance in highly regulated environment. Personnel recruitment, performance management, budgetary management, Technical SME. Vendor management for support and development vendors within remit. Accomplishments: • Consolidation of enterprise Labeling & UDI systems ($1M/yr savings) • Application lead for USA Order to Cash batch management integration (SAP) • MDM / UDI integration and governance initiative leadership • EUDAMED UDI sponsor/IT lead for technical implementation of EUDAMED requirements • Reduction in support response time while supporting increased system operations • Uptime of systems in operational area at greater than 99.9% (24/7 uptime requirement)
Leader of engineering/specialist team focused on electronic Instructions for Use (IFU/IFP) implementation, content management systems, destination labeling, and global translation of labeling. Includes personnel recruitment, performance management, budgetary management. Global process owner: oversight of labeling standards, human factors engineering, requirements, data, technical solutions, business process, infrastructure, licenses, suppliers. Accountable for maintaining collaborative relationships ensuring robust system implementation, business process success, and efficient compliance. Accomplishments: • Launch (+validate) of electronic IFU (eIFU) website/digital document conversion ahead of schedule • Successful contract negotiation/vendor management: eIFU, translation SaaS providers • Development and launch of destination labeling and content management systems • Led eIFU project to realize $324,000 in 18-month savings, breakeven within 24 months
Initiate, plan, implement, and close strategic Quality/Regulatory/Supply Chain projects focusing on Infrastructure (software, systems), Integration (10 QMS entities), Compliance (changing regulations), New Products, Supplier Management, etc. Management of validation (CSV) team personnel. • Planning and completion of ISO 13485:2016, MDSAP, and MDR readiness actions • Planned and implemented software solutions for product data management, labeling, quality system records (complaints, CAPAs, NCMRs), supplier data management, etc. • Divestiture / Integration: Technical Service Agreement drafting, management, closure • Quality Agreement / Divestiture / Integration leadership (30+ completed) • Computer System Enablement, Validation (CSV), and portfolio remediation
Responsible for complaints process. Coordinate onsite and offsite investigations ensuring timely completion, reporting, and data quality. US complaint database owner and US complaint process SME. Responsible for ensuring product and process quality through trend analysis, data analysis, investigation analysis, and surveillance. Controller, administrator, and SME of vigilance and reporting (MDR/MDV) for US complaints. Responsible for establishing complaint metrics, methodologies, and escalation (management review, CAPA, quality data streams). Trainer for US personnel on matters of quality. Lead and assist with projects involving CAPA, non-conformance, field action, and process improvement including work with cross-functional teams (Customer Service, Distribution, Engineering, Inventory, IT, Marketing, Regulatory, R&D, Sales, Sourcing). Revamping and writing field action SOPs. Site SME for software validation. Currently training on software validation. Analyzing Post Market procedures in order to improve process and maintain compliance. Assisting in continuous compliance (quality and regulatory) to 21 CFR (parts 11, 801, 803, 806, 807, 820, 822) regulations and ISO standards (13485). Accomplishments: Investigation of two CAPA files and action completion of another two CAPA files Completed processing on backlog of complaint files Reduction in number of open complaints by over 60% Reduction in processing time for complaints by 180 days Closure and resolution of 100% of open distribution issues (complaints and non-conformances) No recurrence of distribution issues since closure Wrote and implemented compliant and audit ready trending program (SOPs, graphics, action limits, escalation criteria, process control) Completion of all data requests (analysis, metrics, and raw) by next day Revamped and wrote a new., detailed field action SOP with cross-functional support Leader of site computer system validation (CSV) efforts, closing compliance gap
Complete file processing of medical device complaints (MDR) and field reports, including customer follow-up, quality checks, CAPA assessment, and risk assessment. After six months with the team, I achieved promotion to an additional assignment analyzing returned medical devices and data. Both roles have involved input on procedures and processes (change control), training of new personnel, and projects with cross-functional teams. As part of a robust team, I have: met or exceeded all objectives, initiated field actions and engineering reviews to ensure product quality, processed thousands of complaints ensuring compliance.
Commercialization and QA of adhesives and composite materials used in automotive applications. Compounded, processed, inspected, measured, tested and analyzed data on thousands of novel materials. QA coordination (inspection, measurement, material testing, and data analysis) of foam core adhesive production runs. Project support to developers, engineers and customer support.
Operated and maintained heavy machinery, performed manual labor, and evaluated forage, grain, legume, and soil samples. Managed small-scale construction, design, and mechanical projects involving problem solving and troubleshooting.