Quality Engineer I
Description
Responsibilities
Verify company’s adherence to the established Quality System and GMP/ISO standards.
Completion of risk management and risk analysis including FMEA.
Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
Conducts technical and statistical investigations concerning optimization and compliance to specification.
Owner of measuring process capability, process controls, and process validation / efforts.
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
Leading Build At Risk (BAR) Authorizations & Closures
Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering.
Support execution and approval of IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, with mentorship from higher level engineering.
Conducting Advanced Statistical Data Analyses using Minitab with minimum mentorship from higher level engineering.
Maintenance/update/Authoring Master Validation Plans and Reports
Support/owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) with mentorship from higher level engineering.
Supports activities during preparation and execution of audits (External / Internal)
Perform other duties and responsibilities as assigned by senior management.