Michael Esposito
San Diego,California
Summary
Diligent Quality Assurance Professional with six years of proven expertise in data-driven quality assurance and engineering. Adept at maintaining meticulous records to uphold strict regulatory standards, ensuring compliance and transparency across production cycles. Recognized for identifying and implementing process enhancements that elevate product quality, minimize defects, and streamline operations, ultimately driving efficiency and enhancing customer satisfaction.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Lead Quality Engineer
Apricorn
Poway, California
08.2024 - Current
- Led the creation and implementation of a comprehensive Incoming Quality Control (IQC) program, ensuring systematic evaluation of all incoming components.
- Documented test results and prepared reports on product quality in accordance with ISO 9001 and 14001 standards.
- Planned, developed, and implemented quality assurance programs to ensure the highest possible level of product reliability.
- Evaluated existing processes and products to identify areas of improvement or non-conformance issues.
- Analyzed defect trends and supplier performance data to develop targeted quality improvement plans
- Maintained accurate documentation regarding inspection activities, test results and corrective actions taken in accordance with company policies and procedures.
Quality Assurance Specialist
Antcom
Los Angeles, California
01.2024 - 04.2024
- Lead final inspection procedures for products, meticulously ensuring adherence to quality standards and customer specifications before shipment.
- Act as a primary point of contact for customer inquiries, concerns, and feedback, effectively communicating with clients to address their needs and resolve any quality-related issues promptly and professionally.
- Develop and maintain robust quality assurance protocols and procedures tailored to the specific requirements of each product line, optimizing efficiency and accuracy in the inspection process.
- Conduct root cause analyses on any defects identified during testing cycles, implementing corrective actions to prevent recurrence and continuously improve product quality.
- Proactively identify opportunities for process improvements in final inspection procedures, driving initiatives to enhance efficiency, reduce defects, and streamline operations.
Quality Assurance Specialist
Elite Pharmaceuticals
Northvale, NJ
08.2022 - 09.2023
- Ensure compliance with all relevant regulatory requirements and guidelines, including FDA and GMP regulations
- Implement and maintain an effective quality assurance program that meets regulatory requirements and ensures the quality of pharmaceutical products
- Developed and conducted training programs for employees on quality assurance processes and regulatory compliance
- Specialized in the development and revision of Standard Operating Procedures using the QT9 platform. Analyzed operational processes to create clear, concise, and accurate procedural documentation. Seamlessly integrated SOPs within the QT9 Quality Management System , ensuring alignment with organizational quality standards and regulatory compliance. Maintained meticulous records and version control of all SOPs in QT9, facilitating effective document management and accessibility.
- Conduct regular internal audits to assess compliance with regulatory requirements and identify areas for improvements
Quality Assurance Specialist
PDI
Orangeburg, NY
05.2020 - 07.2022
- Resolved critical operational problems by performing root cause analyses and implementing corrective actions
- Enhanced quality initiatives by reviewing, assessing, and continuously updating standards
- Coached and mentored others in proper and effective use of quality tools and systems
- Served as SME for internal and external audits
- Improved manual processes and drove opportunities to map and automate numerous procedures
- Defined and helped govern quality systems by authoring procedures and work instructions.
- Streamlined SOP creation and integration via MasterControl, ensuring precision, compliance, and accessibility. Maintained meticulous document management and version control.
Quality Inspector
PDI
Orangeburg, NY
05.2018 - 05.2020
- Improved performance of production staff and reduced errors with detailed non-conformance reports
- Validated fabrication process and verified conformance with requirements by performing first-piece inspections
- Created quality control plans based on project-specific technical documentation and requirements
- Interpreted blueprints and engineering documents to determine quality requirements
- Wrote non-conformance reports detailing product defects and quantity of rejected items
- Reviewed incoming products and materials as part of final acceptance process.
Education
Audio Production Bachelors Degree -
Full Sail University
Skills
- Quality Issue Identification
- Technical Writing
- Data Analysis
- Internal/external Audits
- Customer Relationship Management
- Final Product Inspection
- Root Cause Analysis
- Quality Assurance Protocols Development
Certification
- IPC-J-STD-001
Timeline
Lead Quality Engineer
Apricorn
08.2024 - Current
Quality Assurance Specialist
Antcom
01.2024 - 04.2024
Quality Assurance Specialist
Elite Pharmaceuticals
08.2022 - 09.2023
Quality Assurance Specialist
PDI
05.2020 - 07.2022
Quality Inspector
PDI
05.2018 - 05.2020
Audio Production Bachelors Degree -
Full Sail University
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