Quality Operations Technician
Core
Perform QA acceptance activities, lot qualification testing, environmental monitoring, and microbiology testing for sterile medical device production.
Role type
Quality Operations Technician (Medical Devices)
Builds
Production release batches and sterile medical device products
Domain
Medical Devices / Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lot qualification testing, in-process quality assurance testing, environmental monitoring, microbiology testing, test method validation, GR&R, data entry, analytical skills, equipment maintenance, calibration, CAPA handling, audit participation
Preferred skills
Microbiology testing experience, test method validation, GR&R, ISO13485 understanding, GLP knowledge
Technologies
SAP, MES, Microsoft Excel
Responsibilities
Perform lot qualification testing of production release; Conduct in-process quality assurance testing, environmental monitoring and microbiology testing; Maintain inspection records and ensure data entered the computer and/or MES/SAP system; Conduct training on usage of tester equipment; Assist Quality Engineer in handling CAPA, NCMR and MRB; Participate in internal or external quality audits
Seniority
Mid-level, hands-on IC