Eva Jimenez

Quality Management Specialist

• Supported the development, implementation, and maintenance of the North America Region Quality Management System (QMS).
• Applied expertise in quality management, including analysis and risk management, to enhance regional processes and systems.
• Created and delivered customized materials for diverse audiences, fostering understanding and engagement.
• Evaluated and drove process harmonization and continuous improvement across the North America Region QMS.

Key Achievements and Responsibilities

• Served as a Subject Matter Expert (SME) for Document Control and Training.
• Led the implementation of new quality processes and procedures to achieve operational excellence.
• Collaborated in cross-organizational networks focused on quality, training, documentation, records management, and technology.
• Played a critical role in preparing for and executing local and external audits.
• Earned ASQ Certified Quality Process Analyst and ASQ Certified Quality Auditor credentials.
• Acted as the North America Regional Network Lead for QMS training and documentation.
• Liaised between NASSC QMS and global QMS initiatives, including Inspire Quality.
• Contributed actively to SAP-DMS, C2C, Central Quality, and IT Change Champion networks

• Evaluated domestic and international complaints to ensure compliance with regulatory requirements (FDA, ISO, QSR).
• Investigated potential product failures and documented findings with trend analysis.
• Drafted customer response letters and identified process gaps, leading to improved instructions and standardization.

Key Accomplishments:

• Managed complex complaints for new product lines and third-party partnerships.
• Received two Gold Star awards for contributions to CAPA initiatives, improving data accuracy and compliance processes.

• Supervised call center documentation to align with HIPAA, SOX, and Medicare Quality Standards.
• Managed company-wide customer feedback and created detailed reports for business insights.

Key Accomplishments:

• Improved online help database usability through data analysis and user feedback.
• Achieved high employee satisfaction ratings in leadership surveys.

• Authored SOPs, work instructions, and reference materials for the call center.
• Designed and implemented an online help database to streamline operations.