Cesar Thomas

Quality Inspection Technician with over 5 years of experience in medical device manufacturing, incoming inspection, supplier quality, and regulatory compliance. Skilled in performing dimensional and visual inspections, interpreting engineering drawings, executing ANSI/ASQ Z1.4 sampling plans, and managing non-conforming materials. Experienced working within ISO 13485 and GMP-regulated environments.

Proficient in the use of precision measuring instruments, ERP systems, and quality documentation processes. Strong analytical, communication, and problem-solving skills with a commitment to maintaining the highest quality standards.

Incoming Inspection Technician at MicroPort CRM / CardioFlow (2024-01 – Present)

• Perform incoming inspections on 100+ material lots monthly while ensuring compliance with ISO 13485 requirements and the inspection procedure for each material.
• Conducted visual and dimensional inspections on critical medical device components using calipers, micrometers, Vertex 251 UC and optical comparator systems.
• Review supplier documentation including Certificates of Conformance (CoC, CoA) material certifications, and inspection reports.
• Investigated and documented non-conforming materials through NCR processes, supporting timely disposition and corrective actions.
• Execute ANSI/ASQ Z1.4 sampling plans and AQL inspections to determine material acceptance.
• Maintain accurate inspection records and update quality status within ERP systems.
• Material containment management to be included in the NCR.
• Support supplier quality initiatives and continuous improvement activities.
• Participate in the Material Review Board (MRB) reunion every month.
• Improvement and update of inspection sheets.

Quality Coordinator at Fedrigoni Group (2022-01 – 2023-12)

• Ensured compliance of product labeling with FDA regulations, ISO 13485 requirements, and Good Manufacturing Practices (GMP).
• Verified the accuracy of product information, barcodes, symbols, warnings, and regulatory content.
• Performed inspections of incoming materials, in-process production, and finished products.
• Investigated quality deviations and non-conformities while coordinating corrective actions with cross-functional teams.
• Maintained quality and regulatory documentation in accordance with company standards.
• Supported continuous improvement initiatives to enhance product quality and compliance.

Incoming Inspection Technician at Medtronic (2020-01 – 2022-12)

• Inspected incoming materials, components, and supplies to ensure compliance with engineering drawings and quality specifications.
• Conducted visual, dimensional, and functional inspections using precision measuring equipment.
• Identified defects and non-conforming materials and documented inspection findings.
• Assisted with supplier quality evaluations and corrective action processes.
• Collaborated with manufacturing and quality teams to maintain compliance with medical device quality standards.

Customer Service Representative & Technical Support at ACS (2018-01 – 2020-12)

• Provided technical and customer support via telephone.
• Resolved customer inquiries and service-related issues efficiently.
• Processed customer transactions and account payments accurately.
• Maintained high customer satisfaction ratings.
• Received the "Quality Service Award" on two occasions for outstanding performance.

ISO 13485 for Medical Device Industries – INFOTEP (2023-01 – 2023-12)

ISO 14971 Risk Management for Medical Devices – INFOTEP (2021-01 – 2021-12)

Good Manufacturing Practices (GMP) – INFOTEP (2021-01 – 2021-12)

Logistics and Supply Chain Management – Quality GB (2015-01 – 2015-12)

Advanced Excel – RH Institute (2016-01 – 2016-12)

Advanced English Program – Instituto Cultural Domínico-Americano (2006-01 – 2009-12)