Chassidy Ellison
West Valley City,UT
Summary
Quality Manger with over 14 years of experience with progressive responsibility in quality assurance and regulatory affairs within the medical device industry. Ethical professional with demonstrated success in maintaining quality systems compliant with applicable regulations. Motivating leader and organized problem-solver with audit execusion, team building and customer service skills. Experienced in stepping into roles and quickly making positive changes to drive company success.
Overview
15
15
years of professional experience
Work History
Quality Manager
Sentient Lasers
Park City, UT
01.2024 - Current
- Ensure compliance with regulatory requirements related to product and service safety and efficacy.
- Perform internal audits of production processes to identify areas of improvement and non-conformities.
- Direct, review, and author of test protocols and reports for installation qualification, operation qualification, and performance qualification validation activities.
- Communicate regularly with management regarding progress towards meeting organizational goals related to product quality.
- Author of standard operating procedures, forms, work instructions, and quality plans, reports for preventive maintenance, decontamination, pest control, and product packaging processes.
- Provided technical guidance on quality control activities to support efficient operations.
- Maintained key quality metrics and key performance indicator to track performance and drive continuous improvement initiatives.
- Monitor product performance against customer specifications and standards, ensuring that all products met the required standards.
- Project manager lead for outsourcing manufacturing line to contract manufacturer, including initiation of quality plan, supplier audit and supplier qualification activities.
Quality Supervisor
Haemonetics USW
Salt Lake, UT
08.2019 - 08.2022
- Participate in third party audits as auditor's point of contact. Interact with third party auditors, providing tours of the premises, answering questions, and providing documentation to contribute to the successful recertification to ISO13485 as well as successful FDA supplier interactions.
- Administrator of Corrective and Preventive Action projects including participation on CAPA team and review and approval of planned actions and final report
- Monitored key performance indicators and presented data during quarterly management review.
- Coordinated the handling and investigation of customer complaints related to product or service quality.
- Collaborate with global sites to address quality-related concerns and facilitate continuous improvement.
- Lead Quality System internal audits to ensure compliance with current Good Manufacturing Practices, site and global company procedures, as well as standards and regulations.
- Perform nonconforming investigations to determine root cause and work closely with various departments to determine corrective actions and prevention planning.
- Manage site calibration activities, ensuring calibrations were performed on time and documenting justification reports for out of specification equipment.
Senior Quality Technician
Haemonetics
Draper, UT
09.2015 - 08.2019
- Owner of new hire employee training program, ensuring training effectiveness for Good Documentation Practices and Good Manufacturing Practices.
- Manage non-conformance program and owner of sort team activities ensuring product accountability and disposition.
- Perform customer complaint investigations to determine root cause, and notified applicable departments of escalation.
- Analyzed data from statistical sampling tests to determine if any adjustments need to be made in order to maintain acceptable levels of quality assurance.
- Lead routine internal audits of the quality system including creating audit plans, executing the audit, and preparing an audit report.
- Supported engineering department with root-cause investigations related to product non-conformance on plasma apheresis disposable devices.
- Member and contributor of the internal site safety committee.
- Collaborated with cross-functional teams including engineering, production, purchasing, to ensure high levels of product quality throughout the entire supply chain.
Quality Technician
Haemonetics
Draper, UT
11.2010 - 09.2015
- Maintained records of all quality department documentation, including inspection, cleaning, environmental reports and data collection sheets.
- Review device history records to ensure compliance with Good Manufacturing and Good Documentation Practices.
- Perform incoming inspections on raw materials using various inspection tools including Smartscope Flash 200, micrometers, calipers, pin gauges, and scales.
- Conduct routine monthly environmental testing including, particulate, viable, and surface sampling
- Document detailed test reports for environmental testing results, initiate non-conformance reports for out of specification results.
Quality Specialist
Boston Scientific
West Valley City, UT
09.2009 - 11.2010
- Trained and mentored new hires on quality system procedures related to medical neurological guidewires.
- Maintained records of test results, training, corrective action, and non-conformance reports.
- Performed incoming inspection and final product acceptance activities, initiate non-conformance if failures occurred.
- Collaborate with engineering department for review of drawing and product specifications prior to production use.
- Ensure non-conformance report completion and product disposition.
Education
Associate of Science -
Salt Lake Community College
01.2025
ISO 13485:2016 Internal Auditor -
BSI Group
01.2020
ISO 19011:2018 Management System Auditing -
BSI Group
01.2020
High School Diploma -
Hunter High School
01.2008
Skills
- Training and Mentoring
- Technical Writing
- Quality Auditing
- Verbal and Written Communication
- Critical Thinking
- Team Collaboration
- Change Management
- Continuous Improvement
Timeline
Quality Manager
Sentient Lasers
01.2024 - Current
Quality Supervisor
Haemonetics USW
08.2019 - 08.2022
Senior Quality Technician
Haemonetics
09.2015 - 08.2019
Quality Technician
Haemonetics
11.2010 - 09.2015
Quality Specialist
Boston Scientific
09.2009 - 11.2010
Associate of Science -
Salt Lake Community College
ISO 13485:2016 Internal Auditor -
BSI Group
ISO 19011:2018 Management System Auditing -
BSI Group
High School Diploma -
Hunter High School
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