Daiana Montes
Quality Assurance Manager
Racine,WI
Summary
Dedicated Quality Management personnel with a 10-years track record providing outstanding food safety and quality standards that are followed in the development, delivery and execution of products and services. Experienced in improving products and procedures by leveraging hands-on inspections, testing,methods and data analysis. Applies critical reasoning to successfully conduct regular Food Safety and Quality Management system. Excellent communication skill, active listening, coach talents, physically fit and adaptable with the capability to work in various work environments.
Overview
13
13
years of professional experience
4
4
Certification
Work History
Quality Assurance Manager
Seda North America
Racine, WI
01.2019 - Current
- Manage and support Food Safety Management System of a 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 Specialist, 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 limit in process defect.
- 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.
QA Manager
Emsur USA
Elk Grove Village, IL
09.2016 - 01.2019
- 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.
QA Specialist
Emsur USA
Elk Grove Village, IL
02.2016 - 08.2016
- 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.
QA Specialist
Columbus Vegetable Oils
Des Plaines, IL
01.2015 - 01.2016
- Monitor product line settings and document issues found.
- Review, analyze and follow up paperwork from Quality Inspections in a daily basis.
- Monitoring and auditing of products to ensure high standards of quality.
- Ensuring products comply with legislation and quality assurance codes.
- Perform RCA's and collaborate with CAPA analysis and maintain CAPA system.
- Provide weekly reports to QA Senior Manager and R&D Manager on personnel performance.
- Identify training needs and recommendations to improve production plant.
- Keeping quality documentation up to date.
- Keep all QA records, data and forms available for managers and auditor.
- Arranging the repair of any QA related equipment that is malfunctioning.
- Ensuring non-conforming products are identified and placed on restriction.
Packaging Supervisor
Georgia Nuts Company
Chicago, IL
07.2014 - 12.2014
- Lead, plan, organize and monitor up to 40 employees in the packaging department.
- Monitor OEE, report line downtime and request maintenance support as needed.
- Coordinate employee training required for safety, quality and operations activities.
- Overseeing quality control and ensuring product compliance.
- Ensure production orders are completed on time.
- Supervising production processes, and adjusting schedule as needed.
- Performance reviews and disciplinary action.
- Cycle count and work in progress inventory management.
Quality Assurance Associate
Sunstar Americas
Chicago, IL
09.2013 - 07.2014
- Implement processes and procedures and conduct analyses 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
- Perform research and analyze data to support CAPA team
- Review technical protocols and reports (verification and validation) based upon relevant standards such as ISO 13485.
- Conduct post-market activities including complaints and CAPA assessments
- Use problem-solving techniques to identify, solve and/or improve process anomalies.
- Review prints, data, procedures, and test protocols/ reports for accuracy and technical application of standards (ISO, ASTM).
Research Assistant
DuPont Pioneer
Salinas, Puerto Rico
03.2011 - 08.2013
- 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.
Education
Bachelor of Science - Chemical Engineering -
University of Puerto Rico Mayagüez
Puerto Rico10.2010
Skills
- Food Safety and Compliance
- HACCP, cGMP, SSOP, FSSC 22000, ISO 13485, BRC, SFI, FSC,PEFC
- Internal and External Audits
- FDA, USDA, CFIA compliance
- Risk Analysis and Mitigation
- Operation Monitoring
- Project Management
- Statistical Process Control
- Data Management
- Customer Complaint Resolution
- CAPA Analysis
- Minitab, VISIO
- SAP- ERP
- Automated process
- Inline Quality Systems
- Policy Reinforcement
- Work Planning and Prioritization
- Budget Management and Preparation
- Employee Recruitment
Certification
- PCQI - 2021
- HACCP for Food Packaging - 2020
- FSSC 22000 V.5.0 - 2020
- HACCP for Food Processor - 2015
- Six Sigma Lean Professional and Change Management Specialist certificate - 2015
- Validation Engineer Seminar- 2010
Accomplishments
- Successfully led and coordinate 5 years consecutive FSSC 22000 audits including three years of zero findings and one unannounced audit. - 2023
- Coordination and implementation of Interstate Milk Shippers certification to support the acquisition of a 15MM dairy business - 2020
- Expansion of quality control audit from 12% in 2018 to 75% of processes in 2020.- 2020
- Implementation of RCA team meeting with cross functional team - 2019
- Implementation of a Supplier Claim Process to report defects related to supply deviations and monitor improvements. - 2019
- 52% customer claims reduction over 4 years - 2019 to 2022
Languages
Spanish
First Language
English
Advanced (C1)
C1
References
References available upon request.
Timeline
Quality Assurance Manager
Seda North America
01.2019 - Current
QA Manager
Emsur USA
09.2016 - 01.2019
QA Specialist
Emsur USA
02.2016 - 08.2016
QA Specialist
Columbus Vegetable Oils
01.2015 - 01.2016
Packaging Supervisor
Georgia Nuts Company
07.2014 - 12.2014
Quality Assurance Associate
Sunstar Americas
09.2013 - 07.2014
Research Assistant
DuPont Pioneer
03.2011 - 08.2013
Bachelor of Science - Chemical Engineering -
University of Puerto Rico Mayagüez
Similar Profiles
Eladio CoronaEladio Corona
Forklift Operator at Seda North AmericaForklift Operator at Seda North America
Nelmar RellamaNelmar Rellama
F&B Server and Bartender at Seda Vertis NorthF&B Server and Bartender at Seda Vertis North
Naftale HirdNaftale Hird
Investments Compliance Manager at QBE North America, Investments Compliance North AmericaInvestments Compliance Manager at QBE North America, Investments Compliance North America
Chelsy ScottChelsy Scott
Independent Contractor at ShiptIndependent Contractor at Shipt
Ronald CarterRonald Carter
Correctional Officer at KMCICorrectional Officer at KMCI