Quality Assurance Reviewer, 2nd Shift
Core
Review device and product records to ensure compliance with release criteria, including batch records, certificates of compliance, and inspection documentation.
Role type
Quality Assurance Reviewer
Builds
Ensures compliance with release criteria for medical devices
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Document review, GMP familiarity, ISO standards knowledge, MS Excel proficiency, regulatory compliance knowledge
Preferred skills
None stated
Technologies
MS Office, Excel
Responsibilities
Performs batch record review and release functions, Reviews certificates of compliance or test reports, Reviews receiving inspection documentation, Reports non-conformances and discrepancies, Generates Excel spreadsheets to record review activities, Ensures that completed batch records and other applicable Quality documents are scanned after completion
Seniority
Entry-level, individual contributor