Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Orlando Quinones Ortiz

Kissimmee,FL

Summary

Detail-oriented and results-driven professional with over 8 years of experience in positions in quality
control, inspection, packaging, and operator mainly within the medical device and biotechnology
sectors. Proven track record in leading quality initiatives, developing and implementing robust quality
systems, and ensuring compliance with industry regulations and standards. Experienced in training and
supervising employees to enhance their skills and ensure adherence to quality protocols, fostering a
culture of continuous improvement. Adept at conducting thorough inspections, managing audits, and
collaborating cross-functionally to improve product quality and operational efficiency. Strong analytical
skills with a focus on data-driven decision-making and a commitment to innovation in manufacturing
processes.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Quality Control Lead/ QA Pre Op Specialist and Hea

Openwater Seafood
Orlando, FL
12.2020 - Current
  • Conducted thorough inspections to ensure production areas were prepared and compliant, collaborating with the Incoming Inspection Coordinator (IIC) for optimal setup.
  • Trained and supervised employees in quality control procedures and best practices, ensuring adherence to safety protocols and fostering a culture of continuous improvement.
  • Performed ATP swabs, allergen swabs, and environmental sponge tests to monitor cleanliness, and prevent contamination in production areas.
  • Executed microbiological testing of raw materials, in-process products, and finished goods to
    ensure safety and compliance with quality standard
  • Verified the accuracy of product labels before and after production runs, ensuring all necessary
    label checks were conducted during the manufacturing process.
  • Conducted audits of Good Manufacturing Practices (GMP), including personal protective
    equipment (PPE) compliance, associate health checks, food handling practices, and process flow
    assessments, providing feedback to management as needed.
  • Performed comprehensive facility audits, including checks for brittle plastics and foreign
    materials to ensure a safe production environment.
  • Monitored and assessed raw materials and finished products to verify compliance with
    established specifications and quality standards.
  • Regularly took and recorded product temperatures at receiving, processing, and storage stages
    to ensure compliance with Critical Control Points (CCP).
  • Conducted routine calibration checks on equipment such as scales, thermometers,
    luminometers, and water pressure devices to maintain accuracy and reliability.
  • Executed chemical concentration checks and visual/tactile inspections to confirm adherence to
    sanitation protocols.
  • Performed pressure tests related to food defense and GMP compliance to ensure operational
    integrity.
  • Assisted in conducting food safety training sessions for employees, enhancing their knowledge
    and adherence to safety protocols.
  • Completed and maintained all necessary regulatory paperwork, ensuring compliance with FDA
    standards for seafood processing.
  • Reviewed batch records meticulously, following FDA standards specifically related to seafood
    processing to ensure traceability and compliance.
  • Maintained certification in Food Defense (FSPCA) to enhance safety protocols within the facility.
  • Utilized INNOVA inventory and production control software for tasks ranging from label setup to
    lot reconciliation, ensuring efficient tracking and documentation.
  • Controlled and maintained all supporting documentation related to BRC (British Retail
    Consortium) standards to uphold quality assurance.
  • Implemented and managed CAPA processes to address non-conformities and improve
    operational practices.
  • Applied Hazard Analysis and Critical Control Points (HACCP) principles to ensure the safety and
    quality of seafood products throughout the processing stages.

Diabetes Sensor Manufacturing

Medtronic
Juncos, PR, Puerto Rico
10.2017 - 11.2018
  • Thoroughly sanitized the designated work area (major and minor) to ensure compliance with
    hygiene and safety standards, preparing for the processing of each batch.
  • Conducted detailed inspections of the sanitized area to confirm that all surfaces and equipment
    met cleanliness and operational standards before beginning work
  • Carefully placed sensors into designated tubes, ensuring proper alignment and secure fit to
    maintain the integrity of the testing process.
  • Executed precise cutting of tubes according to specified measurements and protocols, ensuring
    minimal waste and maintaining product quality.
  • Packaged each batch systematically, following established protocols to ensure that products
    were securely and accurately prepared for dispatch.
  • Coordinated the dispatch of each batch, verifying that all documentation was complete and that
    products were labeled correctly for delivery.

Manufacturing Technician and Quality Inspector

Aspen Surgical a Hill-Rom Co
Las Piedras, PR, Puerto Rico
01.2016 - 03.2017
  •  Operated machinery to manufacture blades, ensuring adherence to specifications and
    production schedules for optimal output.
  • Conducted thorough quality checks on blades throughout the manufacturing process, verifying
    dimensions, sharpness, and finish to ensure compliance with quality standards.
  • Efficiently fed raw materials into the manufacturing machines, monitoring the feeding process
    to minimize waste and prevent operational disruptions.
  • Received incoming materials, ensuring that all shipments were accurately logged and matched
    purchase orders for inventory control.
  • Inspected materials before production to identify any defects or inconsistencies, ensuring only
    high-quality materials were used in the manufacturing process.
  • Maintained accurate records of production runs, quality checks, and material inspections to
    support traceability and regulatory compliance.
  • Worked closely with team members and supervisors to troubleshoot production issues,
    implement improvements, and maintain a safe working environment.

Manufacturing Process Technician & Inspector

St Jude Medical Inc
Caguas, PR, Puerto Rico
06.2013 - 12.2014
  • Operated precision machinery to manufacture heart valves, adhering to strict specifications and
    production protocols to ensure optimal quality and functionality.
  • Conducted thorough sanitization of all utensils and tools used in the manufacturing process,
    following industry standards to prevent contamination and maintain a sterile environment.
  • Performed detailed inspections of finished heart valves to assess quality, functionality, and
    adherence to regulatory standards, documenting any defects or deviations.
  • Executed sterilization processes for finished heart valves, ensuring that all products met strict
    sterility requirements prior to packaging and distribution.
  • Maintained comprehensive records of manufacturing processes, inspections, and sterilization
    results to ensure traceability and compliance with regulatory guidelines.
  • Collaborated with the quality control team to address any quality concerns, implement
    corrective actions, and improve manufacturing processes.
  • Ensured compliance with safety and health regulations in the manufacturing area, promoting a
    safe working environment for all personnel.

Associate Manufacturing Process Technician

Amgen Manufacturing Limited
Juncos, PR, Puerto Rico
03.2011 - 07.2012
  • Conducted detailed inspections of syringes and vials during the manufacturing process to ensure
    adherence to quality standards, specifications, and regulatory compliance.
  • Performed thorough inspections of packaged products, verifying that all packaging was secure,
    correctly labeled, and met quality criteria before distribution.
  • Received incoming materials, ensuring accurate logging and tracking of all components required
    for syringe and vial manufacturing.
  • Verified and counted all received materials against purchase orders to confirm accuracy and
    ensure the proper quantities were available for production.
  • Implemented major and minor sanitization procedures for production areas and equipment to
    maintain a sterile environment and prevent contamination.
  • Maintained accurate records of inspections, material receipts, and sanitization processes to
    support traceability and compliance with industry regulations.
  • Collaborated with manufacturing and packaging teams to identify and resolve quality issues,
    promoting continuous improvement in processes.
  • Ensured compliance with safety protocols and regulations in all inspection activities, fostering a
    safe working environment.

Education

Associate of Arts - Culinary

Escuela Hotelera De San Juan
San Juan, PR
07-2017

Skills

  • Bilingual (English and Spanish)
  • Capacity for teamwork, critical thinking under pressure and prioritize tasks
  • Responsible, punctual, quick learning, detail oriented, and quality conscious
  • Analytical, logical thought process and meticulous attention to detail
  • Excellent interpersonal and organizational skills
  • Good Manufacturing Practices (GMPs)
  • Quality and Safety Standards: Proficiency in Microsoft Teams, Word, PowerPoint, and Excel
  • Proficiency in Microsoft Teams, Word, PowerPoint, and Excel

Certification

  • FSPCA
  • Food Safety Preventive Controls Alliance
  • Servsafe
  • Seafood HACCP

Timeline

Quality Control Lead/ QA Pre Op Specialist and Hea

Openwater Seafood
12.2020 - Current

Diabetes Sensor Manufacturing

Medtronic
10.2017 - 11.2018

Manufacturing Technician and Quality Inspector

Aspen Surgical a Hill-Rom Co
01.2016 - 03.2017

Manufacturing Process Technician & Inspector

St Jude Medical Inc
06.2013 - 12.2014

Associate Manufacturing Process Technician

Amgen Manufacturing Limited
03.2011 - 07.2012
  • FSPCA
  • Food Safety Preventive Controls Alliance
  • Servsafe
  • Seafood HACCP

Associate of Arts - Culinary

Escuela Hotelera De San Juan

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Orlando Quinones Ortiz