Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures
Job Summary
Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures.
Complete product release activities of products post sterilization and identify and report non-conformances.
Employee benefits include medical, dental, vision, flexible spending accounts, disability plans, 401K, pet insurance, and an employee stock purchase plan.
Matching Summary
Review device history records for accuracy and regulatory compliance and compliance to TransMedics procedures.
Skills & Requirements
Must-have
device history record review
regulatory compliance adherence
product release post sterilization
non-conformance identification
quality and detail oriented
Nice-to-have
excellent interpersonal skills
self-motivation and adaptability
positive attitude
team collaboration
Key Requirements
Associates Degree
one year experience in DHR or batch record review
three years experience in FDA regulated environment