Jeanette Ramírez Rocha

Quality Management System (QMS)

• Regularly update and maintain the QMS, ensuring compliance with company standards and regulatory requirements.
• Collaborate with Demant Holding’s QMS administrators and internal departments to develop and update procedures.
• Manage internal audit processes, including scheduling, auditor appointments, and report reviews for Mexico.
• Oversee the CAPA system, including approvals, assessments, and closures, and serve as CAPA approver and QA Representative.
• Conduct QMS training and support internal development to ensure team competence and compliance
• Coordinate and participate in external audits, ensuring smooth execution and compliance.
• Review, approve, and manage QMS documents, ensuring proper version control.
• Administer QMS documentation directories and maintain both digital and physical files.
• Create and present quality reports to top management for reviews and improvement actions.
• Oversee local document control, CAPA, and NCR processes to ensure system consistency.

• Developed local inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
• Performed quality inspections and drafted reports to detail non-conforming material issues.
• Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
• Optimized incoming inspection procedures by working closely with receiving personnel, reducing wait times for materials needed in production lines.
• Ensured adherence to quality standards by conducting thorough inspections of incoming materials.

• Supplier Quality Monitoring: Track and evaluate supplier quality performance using a monthly balanced scorecard, ensuring adherence to established quality standards.
• Supplier Qualification & Auditing: Lead and participate in supplier qualification and evaluation, conducting quality management system audits and special process audits to assess supplier capabilities.
• Collaboration for Continuous Improvement: Work closely with suppliers to review their quality assurance processes and procedures, driving continuous improvement in both supplier and product performance.
• New Product Launch Support: Ensure supplier quality aligns with required standards for new product launches, adhering to AIAG CQI-19 guidelines.
• Advanced Quality Planning: Apply advanced quality planning tools, including SPC, FMEA, Control Plans, and Measurement System Analysis, to evaluate suppliers' manufacturing capabilities and process stability.
• Incoming Inspection Management: Organize and prioritize incoming inspection activities, ensuring raw materials meet specifications and are promptly released for production

• QMS Maintenance & Improvement: Oversee the ongoing maintenance and continuous improvement of the Quality Management System (QMS), ensuring alignment with business objectives and industry standards.
• Audit Coordination & Execution: Schedule, plan, execute, and evaluate audit activities, ensuring thorough post-audit follow-up and corrective action implementation.
• CARs & Non-Conformance Management: Manage, monitor, and maintain customer corrective and preventative actions (CARs), internal non-conformances, and the overall QMS to drive consistent quality improvements.
• Quality Documentation Oversight: Maintain and update Quality Manuals and Procedures, ensuring that the content remains relevant and aligned with business needs.
• Management Review Coordination: Coordinate and execute Management Reviews, facilitating discussions on quality performance and areas for improvement.
• Supplier Corrective Action Management: Issue and track supplier corrective actions using 8D and Six Sigma methodologies, ensuring timely and effective resolution of quality issues.
• RMA Process Coordination: Oversee the Return Merchandise Authorization (RMA) process, including issuing, receiving, analyzing, and closing RMAs to ensure efficient handling of product returns and customer satisfaction

• RMA Process Coordination: Manage the full RMA process, including issuing, receiving, analyzing, and closing RMAs, ensuring efficient handling of returns and customer satisfaction.
• Market Quality Measurement: Establish, maintain, and track key quality metrics to monitor and improve market quality performance.
• Monthly Reporting: Collaborate with management to generate comprehensive monthly reports on overall product quality, providing actionable insights for improvement.
• Process Documentation Development: Develop Process Flowcharts, Control Plans, and PFMEAs in collaboration with key departments to enhance product and process consistency.
• Inspection & Testing Optimization: Develop and refine methods for inspection, testing, sampling, and training to improve quality assurance processes.
• Corrective Action Follow-Up: Ensure the timely follow-up, verification, and validation of corrective actions to resolve quality and process issues effectively.
• Quality & Process Issue Resolution: Proactively identify and resolve quality and process-related issues to maintain high standards of production and customer satisfaction.

• Quality Evaluations Coordination: Oversee quality evaluations during both pre-production and mass production stages, ensuring all requirements are met for product quality.
• Issue Monitoring & Review: Track and review all quality-related issues arising during pre-production and mass production, ensuring timely resolution.
• Product Safety & Reliability: Monitor and follow up on finished goods, ensuring product safety and reliability through thorough evaluations.
• Customer Issue Resolution: Report, validate, and address quality issues directly with customers, ensuring effective communication and problem-solving.
• Shipping Confirmation Coordination: Coordinate shipping confirmation meetings to ensure products are market-ready and meet all requirements.

• QMS Certification & Maintenance: Oversee the certification and continuous maintenance of the Quality Management System (QMS), ensuring ongoing compliance with ISO 13485:2003 and ISO 9001:2015 standards.
• ISO 13485 Implementation: Lead the successful implementation of the Quality System for ISO 13485:2003 certification, ensuring alignment with regulatory and industry standards.
• Resource Coordination: Manage and allocate resources effectively to support the successful implementation and maintenance of ISO 13485 compliance.
• Procedure Creation: Develop and implement mandatory procedures in compliance with 21 CFR 820 and ISO 13485 to ensure consistent quality practices.

• Environmental Quality Management System (EQMS): Manage the certification and ongoing maintenance of the Environmental Quality Management System, ensuring compliance with environmental standards and regulations.
• New Model Introduction: Oversee the introduction of new models, ensuring environmental compliance and smooth integration into production.
• XRF Testing: Conduct X-ray fluorescence spectrometry (XRF) testing to ensure material compliance with environmental regulations and quality standards.
• Environmental Compliance: Ensure environmental parts approvals for RoHS, REACH, and Conflict Minerals, maintaining compliance with industry environmental standards.
• Supplier Auditing & Certification: Lead supplier audits and certification processes, ensuring that suppliers meet environmental quality standards and regulatory requirements.

• Implementation and Maintenance of the environmental management
• Performance of Internal Audits and attendance of External Audits
• Management and Disposal of Hazardous and Special Waste