Quality Management Systems Specialist
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Specialist in regulatory affairs and quality assurance. Previous experience in medical device manufacturing and currently employed in pet food manufacturing.
Managing quality systems and investigating root-cause issues with a flexible solution in mind is my passion, and I strive to constantly expand my knowledge and experience.
Certified under BSI to act as Lead Auditor per ISO 13485:2016 and audit quality systems to ISO 19011:2018. Trained to operate as a site's SQF Practitioner and maintain a facility's HACCP Plan(s) with a risk-based approach.
Blendco LLC - Stevensville, MI | February 2024 - February 2025
Under the title of MQA HACCP Coordinator, obtained certification and continuous training for Hazard Analysis Critical Control Points and Safe Quality Food to operate as the facility's SQF Practitioner. Maintained and assisted in the continuous improvement of the facility's food safety and defense culture within the QA Team and under the MQA Site Manager.
Designed, documented, and assessed efficiency of various types of Plant Trial Reports (PTRs) with collaborative efforts from various departments (both on-site and off). This involved developing customer-specific testing and documentation for recording quality checks and other requirements.
Developed and implemented a risk-based assessment for the facility's Environmental Monitoring Program, ensuring future reviews of the program would have all the prior data in one place to gauge occurrence and detection of site sampling.
Maitland Engineering, Inc. - South Bend, IN | April 2022 - February 2024
Assisted the Quality Assurance Manager in maintaining the company's quality management system. Investigated, analyzed, and documented root cause in any non-conformances to determine appropriate Corrective / Preventive Action (CAPA).
Developed a system for categorizing chemicals used on-site for each ingredient and its corresponding Chemical Abstracts Service (CAS) number and any regulatory restrictions that correlated.
Certified under ISO 13485:2016 and 19011:2018 for Internal and Lead Auditor on Medical Device Quality Management Systems.
Associate of Arts - Liberal Arts and Sciences | December 2019
