Quality Assurance Technician
Core
Assisting the Plant QA Manager in maintaining quality system requirements, monitoring sterilization process history, and supporting regulatory compliance for medical device and pharmaceutical sterilization.
Role type
Quality Assurance Technician
Builds
Sterilization process history records and quality data for medical devices and pharmaceuticals
Domain
Healthcare / Medical Device Sterilization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data analysis in databases/spreadsheets, reading batch records, executing re-validation studies, environmental monitoring, audit assistance, training program maintenance
Preferred skills
Experience in sterilization environment, computer proficiency
Technologies
Databases, spreadsheets
Responsibilities
Provide data on plant quality system status, assist with corrective actions and process improvements, monitor quality of sterilization batch records, issue release of processed materials, assist with FDA/ISO/GMP audits, analyze temperature and humidity probe data, maintain quality training programs
Seniority
Entry-level, hands-on IC