Daiana Montes

• Direct Food Safety and Quality Audit ready strategy though strong quality culture and management involvement.
• Co-led teams across operations, design, and sales to deliver three new products, enhancing portfolio by 25% in 2025.
• Develop long-term quality strategies that align with organizational goals and contribute to the optimization of resources.
• Implementation of automated systems to improve KPI accuracy and reliability.
• Oversee the quality performance of suppliers to align and ensure that all materials and components meet organizational standards.
• Governance of plant and warehouse FSMS and QMS including the management of FSSC 22000, Chain of Custody of FSC, SFI and PEFC, sustainable ISSC Plus, and many independent customer audits.
• Manage and process all Regulatory Compliance and Stewardship programs for US and Canada market.
• Provide guidance and ensure compliance to State and Federal laws applicable to food contact packaging including FDA 21 CFR, CFIA (Canada Food Inspection Agency), USDA among others.
• Analyzed quality data trends to inform strategic decisions and improve overall product offerings.
• Established key performance indicators (KPIs) for monitoring quality assurance effectiveness across operations.

• Manage and support Food Safety Management System of a food packaging manufacturing plant over 500,000 square feet and two warehouse of almost 400,000 square feet under a GFSI scheme.
• Provide hands-on management of the elements of the QMS (Quality Management System), these including quality action plans, corrective actions, supplier quality management, customer complaints, standard work instructions, audit process development, standard operating procedures, test methods and process controls.
• Manage and process all Regulatory Compliance and Stewardship programs for US and Canada market.
• Provide guidance and ensure compliance to State and Federal laws applicable to food contact packaging including FDA 21 CFR, CFIA (Canada Food Inspection Agency), USDA among others.
• Ensure product food safety compliance completing testing such as Specific and Overall Migrations, Chemical absence and heat resistance.
• Lead and support a team of 13+ Quality Engineer, Quality Inspectors, Lab Tech, Validation Tech and Nonconformance Coordinator to ensure programs are success.
• Coordinate Change Control and Process Validation.
• Conduct current and new vendor assessment to ensure compliance and quality standards including written assessment, on site audits, review and update of specifications/COC and on site trials, as needed.
• Monitor raw/packaging material quality as per standard specifications to confirm final products quality and make the process corrections.
• Identify, develop and implement new product introduction- quality management plan, including but not limited to key process indicators, testing plan and frequency for all manufacturing processes.

• Implement internal quality metrics and develop series of quality workshop activities to improve quality culture. Overall decreased work in progress scrap by 15%
• Implement operator monthly quality training program to ensure proper in line quality controls.
• Review and maintain customer specifications.
• Lead FMEA analysis and provide improvement solutions for quality production.
• Directly manage and coach quality auditors to achieve continuous auditing of the quality levels in the plant.
• Lead and coordinate all internal audits and external GFSI BRC, USDA- IMS and customer audits.
• Lead and coordinate Sustainable Sources fibers certifications such as SFI and FSC.
• Lead all quality communication presentation meetings with employees, steering committee, executive management and directly with customer.
• Manage all customer complaints and resolution, reporting and trends monitoring.
• Drives process improvements initiatives. Led cross functional teams in the executing of FMEA, Fishbone, 5 Whys exercises to reduce defects and achieve improvements.
• Collaborate with the development and implementation for new shrink sleeve technology, process controls, auditing plan and specifications.

• Audit production daily processes, document parameters and data collection.
• Review 100% in process and finish good product and evaluation according QA Plan Record keeping of daily internal findings and analysis Quality testing according Quality Plan and customer requirements Enter and maintain all data into ERP system.
• Investigation nonconformities and customer complaints.
• Ensure all quality control procedures are being followed performed investigations as assigned by the Quality Manager or customer Calibration Program and associated record Monthly GMP audits.
• Maintenance documentation, (lab testing, CoA, quality audits) Support QA manager with Training for new employees in quality policies and procedures.
• Support QA manager with quality meetings for production employees Microbiological sample testing, collection and monthly submittal.
• Created quality communication board and update quality presentations including: KPI trends, Quality cost internal and external claims, action plans and progress.

September 2013 - January 2016
Sunstar Americas - Quality Assurance Associate, Chicago, IL
• Implement processes and procedures and conduct analyses to sustain and improve the Quality Management Systems in accordance to ISO 13985.
• Support Quality Specialist to generate and release Engineering Change Notices and implement document controls.
• Prioritize activities and allocate resources for greatest effectiveness.
• Maintained compliance with ISO 13485, supporting internal audits and external regulatory inspections.
• Executed IQ/OQ/PQ validations for new equipment and process changes.
• Conducted SPC studies to improve process capability (Cp/Cpk)
Conducted comprehensive quality audits to ensure compliance with regulatoryanalyses to sustain and
improve the Quality Management Systems.
•
Support Quality Specialist to generate and release Engineering Change Notices
and implement document controls.
•
Prioritize activities and allocate resources for greatest • effectiveness
• Perform Quality functions including procedure writing, inspection and testing
Conducted comprehensive quality audits to ensure compliance with regulatory
standard

• Serve as a research assistant in a biotech research laboratory to support execution of fields operations in the ATI nursery to process all the conversions reducing the cycle of the corn and sorghum crops.
• Conducted primary and secondary research to identify relevant information for project development.
• Managed multiple research projects simultaneously while ensuring accurate record keeping.
• Monitored progress of projects to ensure timely completion within budget constraints.
• Collect data and report statistics in monthly basis of recovery rate, nursery time reduction and harvesting metrics.