Meghan Meeuwissen Email & Phone Number

Elkton, Maryland

• Re-established product team technical strategy, priorities, and structure after major disruption, enabling re-initiation of several deriviative and continuous improvement efforts and driving appropriate progress to targets.• Led and supported multiple derivative efforts, performing activities for project management, technical assessment and validation, design control documentation, design transfer to manufacturing, and technical coaching. • Improved robustness of quality documentation and audit-readiness by identifying reccuring gaps, influencing a change in expectation, and driving best practices across multiple product teams. Current Design Control process owner.

• Led team of shared sterilization and environmental associates – driving alignment of priorities across multiple business groups, escalating needs highlighted by the team for resourcing, ensuring appropriate SME consultation, driving performance and development needs of associates.• Identified, drove, or implemented multiple continuous improvement and supply chain projects across product and shared services, reducing risk of disruption to manufacturing, improving audit-readiness, and enabling projected cost savings of $150k+ year over year.

Elkton, Md

Elkton, Md

• Headed development and commercialization efforts supporting component of new medical product; acted as project manager and supporting technical specification development, validation, and manufacturing transfer activities• Championed several successful revalidation efforts to update raw materials and enable transition of materials to preferred equipment, achieving compliance with international guidances for materials• Investigated quality issues related to calibration nonconformances, downstream complaints, and manufacturing disruptions; provided line support for multiple products and quality control test station• Developed and administrered functional excellence initiatives relative to quality system guidance, root cause analysis, test method validation, technical writing and review expectations• Effectively partnered with downstream divisional project champions and leadership regarding technical updates, project status, and processes for R&D product shipments / certification

• Owned incoming and final product quality control testing areas and supplier quality for Allentown manufacturing site.• Revamped Supplier Corrective Action Notifications process to structure response survey, define roles and responsibilities, and revise flow to reduce resolution time and improve effectiveness of program• Resolved incoming product failures with supplier on portfolio worth $40 million in sales per year; ensured supply to customers through timeliness of corrective actions and demonstrated efficacy of actions• Drove non-conformance root cause investigations, specification creation and interpretation, quality control test plan development, and resolution of issues with suppliers.• Assisted strategic purchasing’s Supplier Management program though auditing, compiling quality data for business reviews, and driving resolution of gaps in supplier control plans

• Investigated patient advocacy trend relative to legacy product for CAPA activities, leading to successful FDA response and prevention of product recall on product worth $1.5 million in annual sales • Implemented corrections and updates to product files for over 100 items comprising $30 million in sales leading to improved compliance and resolution of systemic inadequacies in documentation• Maintained and created risk documentation and Design History Files as project team leader for Pharmacy, Vascular Access, IV, and Pain Control product lines• Created test protocols for product design verification testing per FDA and ISO guidelines to ensure fitness-for-use and oversaw execution of testing• Interacted with marketing counterparts, suppliers, and clinical consultants to develop user requirements and specifications for new products or product enhancements

Bs

Education record