Quality Operations Technician
Core
Perform QA Acceptance activities including lot qualification testing, in-process quality assurance testing, environmental monitoring, and microbiology testing for sterile release products.
Role type
Quality Operations Technician (Medical Device Manufacturing)
Builds
Production release lots and sterile medical device products
Domain
Medical device manufacturing / Sterile processing
Required skills
Lot qualification testing, In-process quality assurance testing, Environmental monitoring, Microbiology testing, First-level troubleshooting, Data entry (MES/SAP), Test method validation, GR&R, ISO13485 compliance, Good Documentation Practices (GDP), GLP knowledge, Microsoft Excel, Analytical skills
Preferred skills
Microbiology testing experience, Test method validation experience, GR&R experience, GLP knowledge
Technologies
MES, SAP, Microsoft Excel
Responsibilities
Perform lot qualification testing of production release; Conduct in-process quality assurance testing, environmental monitoring and microbiology testing; Perform first level troubleshooting of product inspection/testing issues; Maintain inspection records and ensure data entered the computer and/or MES/SAP system; Track and trend qualification test data and provide routine feedback to Quality Engineer; Participate in internal or external quality audits; Conduct training on usage of tester equipment
Seniority
Mid-level, hands-on IC