Anabelle Soriano

Experience

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  Santo Domingo's Institute of Technology

  Jan 2019 - Mar 2021

  Laboratory Intern

  Industrial Processes Laboratory, IPL & HTEC• Implement 5S project• Manage documentation

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  Laminados Industriales EIRL

  Feb 2020 - Apr 2020

  Consulting Intern

  • Implement an automated inventory pilot, programmed by Excel Macros.• Apply 5S to inventory warehouse.

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  Ofimatic

  Apr 2020 - Jan 2021

  Consulting Intern

  • Implements Quality Management System from level 1 to 4 (Macro-processes to procedures).• Maps and connects the different processes within the different departments of the company, through flowcharts, from levels 1 to 3.• Gathers and documents procedures (level 4) following ISO 9001 standards.

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  Fresenius Kabi

  Jan 2021 - Oct 2022

  • 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 and data interpretation.• Perform complaint investigation through effective and established complaint handling processes to determine root cause and appropriate CAPA by prioritizing multiple risk projects to ensure compliance with regulations and standard operating procedures.• Work with multidisciplinary and cross-functional teams from others Fresenius Kabi sites to facilitate the complaint investigation process and ensure the timely completion and closure of complaints.• Participate as a support in the maintenance of the Corrective and Preventive Action System (CAPA) related to customer complaints.• Participating and collaborating objectively with local team members to achieve consistent process while identifying process improvements to drive efficiency and compliance.• Coordinates additional investigations related to escalated complaints on time reporting of ADE, MDR, FARs to the FDA and other Regulatory Agencies. Show less

  • Complaint Quality Engineer I

    May 2022 - Oct 2022

  • Complaint, Quality Engineer Jr

    Mar 2021 - Jun 2022

  • Complaint Analyst

    Jan 2021 - Mar 2021
• 

  The EF Precision Group

  Jan 2023 - Feb 2024

  Quality Engineer

  The Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that product meet customer specifications.1. Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products.2. Ensures products meet the organizations and customers' quality and product integrity requirements.3. Supports product development or operations team by providing analysis and expertise throughout the inspection process.4. Identifies root causes of problems in the production process; recommends and/or implements corrective measures.5. Analyzes data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects. Show less

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  Nicomatic

  Feb 2024 - now

  Quality Assurance Engineer

  · Supports and improves the AS9100/ISO 9001 quality assurance system.· Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.· Maintains, enforces, and measures quality assurance processes.· Leads and prepares internal audits.· Plans and leads supplier’s audits.· Participates and prepares customer audits.· Participates and leads monthly KPI meeting.· Coordinates product testing processes.· Participates in product testing.· Leads product nonconformance investigations.· Identifies and analyzes issues, bugs, defects, and other problems; recommends and facilitates solutions to these issues.· First Article Inspection approval. · Supports and prepares the management review.· Leads product nonconformance investigations.· Prepares documents for customers (source inspection, etc.).· Reviews client, customer, and user feedback. Show less