As a company we will be committed to meeting and exceeding all customer and regulatory requirements while maintaining an effective and successful Quality Management System.
Skills
Bilingual: Spanish and English
Proficiency in Microsoft & ERP systems
Ambitious with good leadership and interpersonal skills
Knowledgeable of ISO 9001 and ISO 13XXX regulations for medical devices
Knowledgeable of SQF, NSF, FDA, FMSA, FSVP, HACCP, HARPC regulations for the food industry
Quality Management System
Internal and External Audits
Work History
01/2020 to Current
Quality Systems SpecialistDairy Farmers Of America – Greenville, SC,
Managed, reviewed, approved and maintained all Quality and Food Safety Programs such as SQF FSSC 22000, ISO 9001, NSF, FDA, GFSI, HACCP, Kosher, Halal, Organic, COO, MSDS, SOP, GDP, GMP, CAPA, RMA, NCR, Food Defense, Change control, COA, AGS, and PEST control programs based on Food Safety certification systems.
Initiated and investigated all customer complaints and/or claims while issuing reports such as SCAR, CAR, RMA, CAPA, HOLD and NCR Reports.
Worked with and contacted suppliers and vendors ensuring the FSMA and FSVP Supplier Verifications Programs are adequate, current and in compliance with processes and procedures.
Developed ingredient and finished product specifications generating a Technical Bulletin; including ingredient statements and nutritional information.
Reviewed, validated and released batch records in accordance to specifications on COA ensuring all microbiological, documentation and ATP testing are performed and validated.
Functioned as the Preventive Controls Qualified Individual to facilitate, review, implement, verify, validate and improve the ongoing continuous food safety programs and process controls in collaboration with all cross functional operation teams.
Established benchmarks and KPIS methods.
Conducted Quality audits such as third-party external audits, customer audits, and internal audits, Ensured compliance of the Mock Recall and Recovery Plan.
Ensured that any Health Department/ USDA/ FDA or other enforcement agency concerns are dealt with quickly and efficiently such that there is no interruption to standard business operations.
Developed and reviewed SOP's and other controlled documents, records, work instructions, templates and forms are in correspondence to the change control programs.
Trained and overseen cross functional departments ensuring all new and current employees are trained and knowledgeable of maintaining Safe Quality Foods and its prerequisites.
Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
Trained and overseen a Quality Team Staff of 15 inspectors. Ensured that quality technicians maintained a desired level of department performance by managing quality assurance checks including monitoring AQL's (acceptable quality checks).
Validated Quality Checks against production specifications for both attribute and variable data collection and managed non-conformance root cause analysis, and CAPA reports.
Conducted Periodic inspections of all aspects of the operation and reported any deficiencies.
Managed Quality Systems such as SQF, GMP, HACCP, ISO 9001 ensuring all external third party audits, customer and internal audits are met.
Ensured documentation is complete, accurate, and properly stored.
Conducted training as necessary for HACCP, GMP, Food Safety, Food Defense, Allergen and other prerequisites.
Interacted with management team to communicate functional department needs and provide recommendations for addressing non-conformances.
Maintained and established records and documents of all production processes.
Reviewed, revised and implemented SOP in compliance with HACCP and SQF.
Certified as an HACCP Coordinator, PCQI and SQF.
Conducted and enforced a Food Defense and HACCP team to ensure the company is continuously improving.
Maintained the supplier monitoring program and collected all corresponding documents such as LOG, COFAs etc.
Ensure all product parameters conforms with specifications.
Implemented a precise Quality Management System to ensure company is within compliance.
Initiated Non-Conformance reports in regards to customer complaints and initiated an investigation
01/2013 to 02/2016
Quality Assurance LeadNtt Data Corporation – Mahwah, NJ,
Performed hourly line clearance visual inspections for all operations performed in a certified ISO 13XXX class 8 cleanroom environments, to ensure all operations and operators meet quality standards.
Inspected medical devices per inspection plan, assuring all in-process medical devices meet the visual inspection criteria and quality standards. Used inspection tools such as eye loops, calipers, scale's and specific TAPPI charts, if necessary.
Supported production processes; maintained a presence on the floor being accessible to production staff when questions arise in order to achieve consistency with quality system regulation.
Verified all documentation such as; Work orders (WO), routers, Work in process (WIP), device history records (DHR). Ensuring the corresponding documents are present at production floor and molding medical device department assuring they are present, corrected, revised and adhered to strict GMP's.
Originated a Non-conformance report (NCR) for non-conforming/rejected product. Referred and investigated customer complaints to exceed customer's expectations to strengthened the corresponding NCR. Stored non-conforming product on hold at quarantine area until further disposition...
Assisted QA Manager with other projects as needed.
Released acceptable In-process medical device and Finished Product.
Reviewed change control documents that relates to technical issues assuring documents meet SOPs before proceeding any further.
Recorded inspection results ensuring a safe and effective work atmosphere and practices by participating in and performing safety training and maintained good housekeeping practices within the 5S Guidelines.
Initiated and/or made suggestions to improve working processes or product (I.E., Quality, Productivity, Etc.)
Set-Up and/or organized QC work stations and receiving quarantine area.
Reviewed Device History Records (DHR) and quality-related documents for accuracy and completeness.
Able to use a variety of measuring and test equipment. Made judgments on the acceptability of the raw and finished products and enforced quality standards.
Performed and conducted Dimensional inspections with the corresponding documents such as; (IP) Inspection Plan and (FAI) First Article Inspection.
Tested all product parameters with GD&T system, TAPPI chart's, eye loop, magnifying lamp, microscope as required to assure the in-process medical devices meet quality standards and collected retained samples per traceability based on given AQL, when required or as needed.
Implemented Medical Device Inspection Blueprint and specification reading Geometric Dimensioning & Tolerance (GD&T).
Worked with; height gauges, calipers, micrometers, optical comparators, thread and ring gauges, eye loops, magnifying lamps, protractors, scales, Flash ram instrument and RAM optical measurement equipment.
Performed critical inspections on all finished goods product categories to ensure conformance to specifications.
Performed receiving inspection per internal documentation and prepared necessary reports.
Monitored and collected quality attributes data for all products manufactured in the molding department to ensure the products meet specifications for record keeping.
Assured that all documentation in the quality department such as; Inspection Plans (IP), Non conformance reports (NCR), Material Safety Data Sheets (MSDS), Corrective and preventive action (CAPA), Standard Operating Procedures (SOP), Blueprints and drawings (etc.) is current, correct, revised and is completed promptly and accurately.
Adhered to the company cGMPs (current good manufacturing practices), safety procedures and all other quality processes.
Worked in a clean room environment, with appropriate PPE (Personal Protective Equipment).
Provided feedback to the lead person and others on possible issues with the production processes and made suggestions for improvements.
Work reflected attention to care, quality and creativity to meet an ISO9001 and ISO13XXX class 8 cleanroom certified company.
Teamwork; worked well with others, provided assistance when needed and helped resolved conflicts.
Education
Expected in 06/2026 to to
Bachelor of Science: Food Sciences And Technology Chaffey College - Rancho Cucamonga, CA GPA:
Expected in 05/2012 to to
High School Diploma: Pomona High School - Pomona, CA GPA:
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