Kate Marmolejo

Project Lead Engineer: Remediation and Validation

Cook Medical

Bloomington, IN

05.2021 - Current

Generated and updated key documents for the manufacturing and quality process (Manufacturing Instructions, Quality Control, SPECs, GIs, etc) as part of remediation activities while actively working with the production and quality team.
Authored and updated Process Flow Maps, Process Validation Plans, PFMEAs, UFMEAs, and associated documentation (MIs, QCs, QSIs, drawings, etc).
Developed Equipment Validation Master Plans and standard operating procedures (SOPs) in compliance with ISO 13485 QMS requirements.
Collaborated with cross-functional teams to troubleshoot and remediate equipment validation failures and deviations.
Developed and executed process validation protocols (IQ, OQ, PQ) in compliance with ISO 13485 QMS and FDA 21 CFR 820.
Conducted risk-based validation in accordance with ISO 14971, ensuring risk mitigation for new manufacturing processes.
Supported supplier qualification and audits, ensuring compliance with ISO 13485 and FDA QSR requirements.
Collaborated in CAPA investigations, performed root cause analysis, and implemented corrective actions per QMS guidelines.(QMS).
Conducted gap analysis for process remediation, implementing corrective actions to address CTQ and CTS deficiencies and ensure regulatory compliance.
Collaborated with cross-functional teams to ensure proper CAPA closure, effectiveness checks, and regulatory documentation.
Investigated product and process non-conformances (NC reports), performed root cause analysis, and implemented necessary corrective actions.
Managed on-time completion of deliverables against client metrics by actively following project plans built with project managers
Managed remediation efforts for seven Remediation and EUMDR Technical File project teams
Trained new personnel on the process validation field to PFMEAs and Process Validation Plans
Ensured compliance with 21 CFR Part 11 for electronic records and signatures in the quality management system
Applied Lean Six Sigma principles to improve validation processes and reduce inefficiencies.