About Ginnette Bonilla

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About me

Accomplished professional with extensive experience in Quality Systems and Customer Complaints in the medical device industry. Hardworking, results-oriented person with ability to handle multiple demands in a fast-paced environment. Proficient in Microsoft Office; Word, Excel, PowerPoint. Bilingual English and Spanish.

Education

Experience

  • 2019 - Present
    Roche Operation

    Quality System Administrator

    Accountable for the quality system management by promoting education, understanding and compliance with regulatory requirements and standards throughout the organization. Executed and decision making related to Non-Conformances (NC’s), Corrective Action & Preventive Action (CAPA) and Customer Complaints. Performed continuous improvements activities to support quality system such as special projects, technical assistance, and training among other ensuring compliance with regulatory requirements. Coach for the nonconformance investigations process. Risk Assessment

Expertise

Nonconforming & CAPA Management Process | Root Cause Investigation | Failure Evaluations | Risk Assessment | Temporary Deviation Notice | CAPA Effectiveness & Verification | SAP SME | Material Master | Bill of Material | MES system

Languages

English
Intermediate

Skills