Cherilyn Johnson

About Cherilyn Johnson

Experienced Senior Consultant with a demonstrated history of working in the biotechnology industry. Skilled in Operations Management, Medical Devices, 21 CFR, ISO, Management, training and Interviewing.

Experience

1. Senior Quality Compliance Specialist

   Edwards Lifesciences

   Nov 2023 — Present · US

   Manage customer relationships and expectations during the course of complaint investigation and resolution process.• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations.• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered.• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA.• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions.• Prepare and submit final customer correspondence.• Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g, Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint.

Education

• Langston University

  Bachelor's degree, Elementary Education and Teaching

  1993 — 1995