Tomas Diaz

Experience

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  Sergen, C por A

  Mar 2015 - Apr 2016

  Electric Technician

  -Repairs of electrical equipment and suppliers of technological. solutions for the hotel sector, from SERGEN, C por A national branch of the ONITY Company.

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  Fresenius Kabi

  Apr 2019 - Dec 2021

  -Lead investigations related to external customer complaints to determine the root cause of the reported defect and measure the effectiveness of actions through trend analysis.-Perform complaint investigation through effective and established complaint handling processes and to determine root cause and appropriate Corrective and Preventive Action System (CAPA)-Familiarity with Quality Management Systems (QMS), Good Documentation Practices, Medical Device Manufacturing. ISO 13485 standards and FDA.-Coordinates additional investigations related to escalated complaints on-time reporting of ADE, MDR, FARs to the FDA and other Regulatory Agencies. -Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CRF 803, 820 & 211; Part 11) Show less -Experience in measure system (MSA).-Failure mode and effect analysis (FMEA).-Support in equipment validations. (IQ, OQ, PQ)-Maintain the Risk Management System for the products/services of the plant and any changes affecting its use or function.-Keep risk assessments up to date-Ensure the correct preparation of all phases of risk assessment. Follow-up of the activities identified in the evaluation process. Determine the effectiveness criteria for implemented actions and then perform the measurement of said effectiveness Show less

  • Complaint Quality Engineer

    Apr 2020 - Dec 2021

  • Quality Engineer Intern

    Apr 2019 - Apr 2020
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  Aptar

  Apr 2022 - Feb 2023

  Quality Assurance Analyst

  • Host customer audits. Respond to customer audit reports. Follow-up on corrective actions resulting from audit observations.• Review customer Quality Agreements and customer specifications to facilitate timely approval by both the customer and internal functions.• Analyze product complaints. Evaluate complaint samples, investigate root cause and generate complaint reports.• Interface with cross-functional teams, such as Manufacturing, Engineering and Technical• Operations, to assist with root cause investigations and corrective action resolution.• Develop relationships with quality contacts at key customer sites. Communicate customer needs and developing quality trends to the Quality Organization.• Support product manufacturing site transfers, including document creation.• Write standard operational procedures in compliance with ISO and cGMP requirements.• Support process improvement initiatives and analyze process performance to identify trends. Show less

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  RegenLab USA

  Feb 2023 - now

  Complaint Coordinator/ Quality Associate

  -Received, verified, and reviewed complaint reports to initiate and document the complaint investigations with understanding of the Post Market Surveillance (PMS) requirements reflected in ISO 13485 Medical Device Single Audit Program (MDSAP), Medical Device Regulations (MDR), and the Quality System Regulation (QMS)-Provided comprehensive graphs and reports pertaining to complaints to both the PMS Director and QA/RA Manager. Reporting Medical Device Reporting (MDR) (21 CFR Part 803) to the FDA, this includes CDRH Form 806.-Continuously analyzed and vigilantly monitored updates from regulatory authorities - regarding post-market field activities.-Conducted and oversaw Non-Conformities (NC), ensured ongoing monitoring andupdates with Change Controls, SOPs, INS, FORMS, and RegenLab’s employee trainingmatrix.-Administered all returns, disposals, and reworks on a weekly schedule in accordance with company standards.-Ensured that prior to commencing each production cycle, a line clearance protocol was diligently executed.-Provided assistance to the quality department in any corrective actions resulting from an audit, internally and externally. Show less