Meaghan Sanchez
Round Rock,TX
Summary
Dedicated and detail-oriented Sterilization Specialist with 5 years of experience ensuring compliance with industry standards and protocols. Proficient in developing and implementing sterility assurance programs to ensure the safety and efficacy of medical devices. Seeking to leverage expertise to contribute to a dynamic medical device company.
Dedicated professional prepared to bring extensive expertise and results-oriented approach to Specialist role. Known for effectively managing tasks and supporting organizational goals through collaborative efforts and adaptive strategies. Recognized for excellent communication and analytical skills, ensuring seamless operations and consistent outcomes.
Overview
6
6
years of professional experience
Work History
Sterilization Specialist
Kyocera Medical Technologies Inc.
04.2024 - Current
- Developed and implemented a comprehensive Dose Audit and Bacterial Endotoxin Monitoring Program, streamlining processes, improving operational efficiency and producing cost savings
- Optimized workflows and standardized procedures, resulting in more timely and accurate monitoring, leading to improvement in compliance with regulatory standards
- Conducted thorough cleaning and sterility assessments of medical instrumentation and non-sterile implants to ensure compliance with regulatory standards and quality guidelines
- Collaborated with cross-functional teams to develop and refine cleaning protocols, improving operational efficiency and reducing sterility-related risks
Microbiologist-Sterilization II
Medtronic
12.2022 - 04.2024
- Develop validation protocols for sterilization validation and requalification
- Conduct risk assessments to identify potential sterility risks associated with manufacturing processes, materials, and equipment
- Perform root cause analyses of sterility failures and non-conformances to determine underlying issues and implement corrective and preventive actions
- Review environmental monitoring deviations and provide impact on product from a sterility assurance standpoint
- Ensure compliance with regulatory requirements such as FDA regulations, ISO standards, and other applicable guidelines
- Maintain quarterly dose audit schedule as well as approving the dose audit reports
Associate Sterilization Specialist
Medtronic
01.2021 - 12.2022
- Contributed to risk assessments and root cause analysis in case of sterilization failures or deviations, implementing corrective and preventive actions (CAPAs) to mitigate future occurrences.
- Monitored and operated sterilization equipment (e.g., autoclaves, gas sterilizers) to ensure proper cycles, temperatures, and humidity for effective sterilization.
- Assisted in the development and optimization of sterilization protocols, ensuring the safety and sterility of medical products while reducing operational inefficiencies.
Sterility Assurance Contract Worker
Medtronic
07.2019 - 01.2021
- Performed data entry of all sterilization records to ensure all cycle specifications were met.
- Manufactured biological indicators for use in Ethylene Oxide requalifications.
- Assisted Senior Sterilization Specialist in performing steam sterilization studies.
- Drafted protocols and product adoption reports for steam sterilization studies.
- Drafted quarterly dose audit reports.
- Consistently met deadlines under pressure while maintaining high-quality work output in a fast-paced environment.
Education
BS - Microbiology
University of Massachusetts
Amherst, MA05.2018
Skills
- Sterilization
- Quality Documentation Skills
- Communication
- Problem Solving
- Continuous Learning
Personal Information
Title: Sterilization Specialist
Timeline
Sterilization Specialist
Kyocera Medical Technologies Inc.
04.2024 - Current
Microbiologist-Sterilization II
Medtronic
12.2022 - 04.2024
Associate Sterilization Specialist
Medtronic
01.2021 - 12.2022
Sterility Assurance Contract Worker
Medtronic
07.2019 - 01.2021
BS - Microbiology
University of Massachusetts
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