Mimi Greer

Maintained a system for storing and retrieving documents, managing document revisions, tracking changes, and ensuring proper document control. Collaborated with Process Owners/Managers/Engineers to ensure documentation supports operational efficiency and assisted with the creation and updating of company documents.

Maintained and filed completed Change Requests to ensure an organized Document Control Center. Organized and separated expired documents from those still within the retention period.

Tracked and completed return's paperwork through its entire life cycle, logging data for accurate tracking and ensuring proper routing for smooth completion of returns and testing. Coordinated with several departments to ensure accurate and timely data sharing and expedited paperwork for priority shipments.

Maintained document lifecycle from creation to releasing ECOs and/or TECOs, ensuring proper documentation classification and submission corrections. Collaborated with the Engineering team to ensure compliance and received recommendations for structuring and transferring documents.

Maintained document control processes and managed an online database to ensure proper uploads, obsoletes, and revisions of documents per ISO 9001. Proactively communicated ECO status to multiple departments and stakeholders, and worked with engineering teams to ensure compliance.

Administered the ECO system, assigning ECO numbers, tracking approval, and verifying compliance with approved procedures and FDA Good Manufacturing Practices. Maintained official files of part drawings, ECOs, procedures, and other official documents in an orderly manner.

Revised departmental procedures to ensure QMS compliance per ISO 13485 and 21 CFR 820, and coordinated quality audits by contacting suppliers and collecting documents. Collected and maintained production data for quality and inventory control, and managed manufacturing/molding tool inventory data.

Received and inspected raw materials for final production, ensuring materials were ready for daily use. Participated in cycle count activities to increase inventory accuracy and maintained equipment and tool availability for manufacturing.

Ensured batch records were completed correctly and data was entered into EBS. Performed quality inspections for raw materials and finished goods, and electronically filed paperwork and pertinent information to appropriate customers.

Completed high school education, providing a foundational academic background.