Bailey Lewis
Quality Engineer at Compumedics
- Role
- Quality Engineer at Compumedics Limited - Official
- Location
- Charlotte, NC, US
- LinkedIn followers
- 500 followers
About Bailey Lewis
Currently working as a Quality Engineer at Compumedics Inc.(Charlotte, NC) in the Quality department.
Experience
Quality Engineer
Compumedics Limited - Official
May 2022 — Present
Main Quality representative based out of the US who maintains the Quality Management system to ensure the company complies with ISO 13485, ISO 27001, FDA, EU MDD/MDR, MDSAP and supplier regulatory and quality requirements. Lead auditee for MDSAP, ISO 13485, 27001 audits Lead auditor of internal audits Assisted with transition from EU MDD to MDR Coordinated Health Canada device licensing and registration Managed FDA facility/device registration and user fees for US site Conducted data analysis and accumulation of quality objective data Created necessary documentation for post-market surveillance activities Maintained documentation and controlled document system globally Assisted with Class I and IIa medical device documentation maintenance
Education
The Catholic University of America
Bachelor's Degree, Bioengineering and Biomedical Engineering
2015 — 2019
CHARLOTTE CHRISTIAN SCHOOL
High School Diploma
2011 — 2015
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