Dustin Monte Montecillo
QA/RA Manager @ Master Medical Equipment | Johns Hopkins MS
- Role
- Quality Assurance and Regulatory Affairs Manager at Master Medical Equipment
- Location
- Memphis, TN, US
- LinkedIn followers
- 500 followers
About Dustin Monte Montecillo
I am an experienced engineer and Johns Hopkins Master of Healthcare Systems Engineering…
Experience
Quality Assurance and Regulatory Affairs Manager
Feb 2024 — Present · Jackson, TN, US
Directed the transition from a paper-based QMS to Qualio, integrating CAPA, Nonconformance, Complaint, Document Control, and Training modules to meet ISO 13485:2016 requirements.Managed full lifecycle of quality events using standardized CAPA and NC forms including investigation, root cause analysis, corrective and preventive action planning, and effectiveness verification.Developed and delivered internal training programs on regulatory requirements, QMS processes, and audit readiness, increasing cross-departmental compliance awareness.Led regulatory affairs initiatives, including identification and implementation of applicable FDA, EPA, IATA, and state-specific regulations, maintaining an up-to-date regulatory database.Coordinated Field Corrective Actions with OEM partners, ensuring timely customer notifications, product remediation, and documentation in compliance with federal and customer requirements.Established and executed supplier quality processes, including evaluation, re-evaluation, and Supplier Corrective Action Requests (SCARs) to maintain approved supplier status.Served as lead internal auditor, developing role-specific audit checklists, training non-quality auditors, and maintaining full-scope ISO 13485 certification across two facilities.Authored and implemented change controls for new and revised QMS documents, ensuring version control, stakeholder review, and proper archival in Qualio.Oversaw complaint handling, ensuring timely intake, risk assessment, investigation, and closure to meet company-defined timelines and regulatory expectations.Utilized data analytics from the CMMS to trend quality events, identify process gaps, and present findings to leadership for continual improvement initiatives.
Education
Mississippi State University
Bachelor of Engineering - BE, Biomedical/Medical Engineering
2015 — 2019
Johns Hopkins Whiting School of Engineering
Master of Science - MS, Healtcare Systems Engineering
2021
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