Quality Engineer I L a V 330pm a 10pm sábados de 8am a 330pm
- Alajuela
- Permanente
- Tiempo completo
Assist in completion of risk management and risk analysis including FMEA.
Supports technical and statistical investigations concerning optimization and compliance to specification.
Assist in 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
Completing and Documenting Monthly Quality Data Review
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 mentorship from higher level engineering.
Executing IQ, OQ, PQ, andor PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.
Conducting Advanced Statistical Data Analyses using Minitab typically with mentorship from higher level
engineering.
Maintenanceupdate to Master Validation Plans and Reports.
Support Major Quality System investigations i.e. CAPAs, HHEs, StopShip, etc. Supports activities during preparation and execution of audits External Internal
Perform other duties and responsibilities as assigned by senior management.
Computrabajo