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.
• 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.

• 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.
• 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.

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