Quality Assurance Management

Jeremy Carrizales

Oxnard, CA ***** ************.**@*****.*** 1-820-***-****

To obtain a position where I can maximize my multilayer of management skills, quality assurance, program development, training experience, customer service and a successful track record of meeting deadlines. I am familiar with instrumentation calibration, auditing and the development of new test methods. Supervisor experience for 6+ years and I excel in time sensitive matters. Experience with regulatory compliance in GMP manufacturing. Quality is always a priority.

Willing to relocate: Anywhere

Authorized to work in the US for any employer

Skilled Quality Professional with eight years of experience in the manufacturing of silicone compounds

Work Experience

QA Receiving Inspector

Eaton - Camarillo, CA

July 2023 to

Present

Visually and manually inspect manufactured parts per acceptance criteria

• Interpret blue prints, assembly drawings, angularity, profile, various datum’s (Vectors) and results from advanced measuring technique (CMM, Keyence, FARO arm) per acceptance criteria.

• Create FAIR and inspection plan documentation, utilizing drawings and standard templates.

• Record/document all receiving, in-process, and final inspection findings as required and initiate Fast Response as needed.

• Achieves and maintain applicable certifications, including plating inspection certification, weld inspector certification, general inspector certification, and hardness testing.

• 5S+ involvement which includes but not limited to your working area

• Uphold quality integrity and generate non-conformance reports when parts do not meet specifications

• Ability to work with MFG-PRO to process parts systematically and WISPER for DMR generations

• Additional Quality specific functions as necessary

QA Supervisor

Kenco - Oxnard, CA

November 2022 to May 2023

Maintain, update, and add as necessary site policies, procedures, standard work instructions, and tools to improve the efficacy of the quality management system.

•Administer internal audit program to ensure compliance to the quality management system throughtraining auditors, auditing processes and procedures, and measuring results.

•Identify training needs and organize training interventions to meet quality standards.

•Investigate customer complaints and non-conformance issues and perform root cause and correctiveaction investigations to improve the quality management system.

•Collect and compile statistical quality data and analyze to identify areas for improvement to the qualitymanagement system.

QA Inspector

DEX - Camarillo, CA

April 2022 to September 2022

Uses standard inspection devices and/or testing equipment and follows checklist or test procedures to set up, check and visually inspect repaired and electronic devices or mechanical devices.

QA Complaints Coordinator

Amgen - Thousand Oaks, CA

May 2020 to November 2021

Responsible for the collecting and analyzing of customer complaint data to provide trending information for further corrective actions and MDR reporting in accordance with FDA regulations.

QA Inspector

Kinamed Inc - Camarillo, CA

August 2018 to September 2020

•Dimensional, mechanical and visual inspections of incoming product according to establishedprocedures. Mechanical abilities for precision inspections using standard and special inspection tools. Ability to use calipers, micrometers, optical comparator, pin and thread gauges. Experience with hardness tester, tensile tester, and fluorescent penetrant inspection.

•Reviews of history records for completeness to ensure proper documentation for identificationand traceability. Works in cross functional teams to achieve company goals. Prepares reports and correspondences as required. Performs outgoing shipment verification's.

QA Complaints Coordinator

Implant Direct - Thousand Oaks, CA

April 2016 to August 2018

Responsible for the collecting and analyzing of customer complaint data to provide trending information for further corrective actions and MDR reporting in accordance with FDA regulations. I was responsible for running daily complaint reports and presenting to the quality team for further actions, as well as the closure of all complaints between the US, EU and ROW.

•Determined MDR reportability of complaints and complete FDA notifications, as required

•Prepared, reviewed and analyzed customer complaint data to determine root cause drivers

•Prepared customer complaint data trending and present to cross-functional audiences, including sales,marketing & engineering personnel

•Performed manual and visual inspections of RMA's

•Support root cause analysis investigations with engineering and QC via CAPA process

•Ensured complaint investigations are thorough and complete while closing complaints

•Monitored and improve tracking/control systems for complaint handling and MDR reporting using

Microsoft Excel or other software applications

•GMP Training, Lean Management and Kaizen experience

QA Technician

Abrisa Technologies - Santa Paula, CA

April 2013 to January 2015

Responsibilities

CAPA

Inspection of raw materials.

Performed internal audits and training. First Articles

QA Supervisor II

Nusil Technology

January 2008 to October 2013

Created corrective action items and implemented them into quality inspection process to detect critical errors.

•Supervised 30 QA associate which included training, daily reports, and auditing each associate.

•Compiled reports for customers to improve the QA testing process.

•Generated and maintained Out of Specification Reports.

•Tracked and reviewed historical data for trends of products.

•Assist with customer's complaints and failing materials.

•Provided final review of completed QC documentation.

•Reviewed, rejected & approved Quality Control Reports for QA.

•Managed final review/signoff of Calibration Reports of all testing and manufacturing equipment.

•Assisted the R&D department for new test method development and looked for ways of improving oursilicone.

•Assisted with investigations and writing deviation reports.

QA Testing Supervisor

Nusil Technology

July 2004 to January 2008

Supervised 20 quality control technicians to inspect each product to make sure it conforms to the regulations of each customer.

•Reported issues to the R&D department for guidance with issues with failures.

•Maintained quarantined and non-conforming materials.

•Performed investigations and deviations.

QA Testing Technician Lead

Nusil Technology

December 1996 to July 2004

Performed incoming raw material and intermediate material testing

- Final product testing per Design Specification/Customer Speciation.

Operator 1

Nusil Technology

September 1996 to December 1996

Manufactured silicone base, gels and final products.

-Performed HPQC testing and final packaging.

-Cleaned, prepped and prepared the equipment.

-Worked with QA Department to resolve testing issues, intermediate and product failures.

-Performed cycle counts in my area of manufacture.

Assistant Operator

Nusil Technology

March 1996 to December 1996

Forklift license.

-Delivered materials to operators by staging materials for the manufacturing of silicone.

-Maintained inventory and the waste/disposal of silicone products.

Education

Diploma

Rio Mesa High School

Skills

•Forklift, first-aid (10+ years)

•ISO (10+ years)

•Quality Assurance

•FDA

•GMP (10+ years)

•Document Control (10+ years)

•Quality Improvement (10+ years)

•Ability to work independently with limited supervision in a pressurised environment. # Accurately reading and interpreting details and technical drawings and blueprints. # Good oral and written communication skills that enable me to communicate well. # Can build the confidence, pride and self-esteem of those who work around her. # Experience of working within a busy and driven manufacturing environment. # Computer literate with knowledge of Microsoft Office.

•Computer Literacy

•Basic Math

•Supervising Experience

•English

•Microsoft Excel

•Packaging

•ERP Systems

•MRP

•Purchasing

•Micrometer

•GLP

•Calipers

•Root Cause Analysis

•Quality Inspection

•Multilingual

•Internal Audits

•Calibration

•FDA Regulations

•Laboratory Experience

•Bilingual

•ISO 9001

•Quality control

•Clinical laboratory experience

•Spanish

Certifications and Licenses

Forklift Certification

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