Honeylette Barros

Develop and implement Quality System for compliance and successful completion of initial ISO 13485 Audit. Support Design Control and Risk Management from concept to commercialization MasterControl System Administrator Project Manager for Quality Process EDMS (Greenlight Guru) Implementation Responsible for CAPA, NCR, Document Control, Supplier Quality

• Implemented and maintained Quality System documents, including transition for ISO 13485:2016 compliance. • Performed root cause analysis of complaint, non-conforming material and corrective & preventive actions systems and lead cross-functional meetings to facilitate investigation. • Implemented methods for tracking, monitoring and analyzing production yield and failure rates for serialized product through multiple processes. • Performed quality control inspection and statistical analysis of quality data. • Scheduled and performed internal audits to ISO 13485:2016, FDA 21 CFR 820 and other international standards, including new MDSAP style audit. • Managed supplier evaluations and monitored supplier performance. Conducted on-site audits for critical suppliers. • Interfaced with auditors during regulatory agency audits • Assisted in implementation of electronic Document Control System (Arena PLM) for released documents, training & reports and ERP system (Expandable)

• Managed mechanical engineering design change projects for orthopedic instruments and firearm accessories product lines. • Developed and iterated prototypes from concept CAD to final product. • Responsible for managing non-conforming materials and documented NCMRs and CAPAs for all builds and received products. • Performed inspections to maintain current and complete Quality Assurance files. • Maintained Document Control System until company growth allowed for training of a Document Control Admin. • Managed consumer complaints, supplier approvals, materials purchasing and inventory levels. • Also contributed to marketing and advertising projects through graphic design and website revisions.

Promoted participation in LLS events and developed communication skills via email and phone. Organized 3 years of files to create and contact a list of potential fundraising teams, sponsors and donors.