Jean Burns Email and Phone Number

• Established an ISO 13485/cGMP quality system that continued to evolve with changes to regulations and standards.• Annual Quality Planning and provided quarterly status updates to executive management.• Developed KPIs that tracked metrics for the facility. Mentored department leads on the establishment of internal tracking metrics.• Management Representative for the facility, leading all FDA inspections, Customer and ISO/MDSAP audits.• Provided QA input/approvals for change orders and other relevant documents.• Coached fellow managers and associates through the non-conformance and CAPA processes. Navigating the group from defining the issue, root cause analysis, plans, any necessary containment, and change controls.• Supported the material review board and documented actions on the open nonconformances or deviations and MRB meeting minutes.• Skilled in reviewing technical reports and validations to ensure clarity and continuity. Provided final review and approval. • Developed and conducted Quarterly Management Review meetings that involved senior executive management and all supporting departments. • Quality member of the design team. Active participation, review and approval of all documents, meeting minutes, risk reviews, harms list review, planning documents, verifications/validations and overall review and final approval of each Design History File (DHF).• Established touchpoints for staff including regular meetings to manage team resources to best address process issues and projects in real time. Kept team focused to ensure attainment of the goal of producing safe and effective products and continued progress toward team goals.• Managed staff that included supervisory, engineering, document control, technicians, and inspectors. Utilized established corporate systems to attract, develop, engage, train, and retain talented associates.• Supported environmental monitoring.Software• MS Office• EtQ Reliance• Camstar • MEDUSA • TMS Web