Quality Engineer I - L a V 3:30pm a 10pm sábados de 8am a 3:30pm

Descripción de la oferta

Responsibilities Verify companys 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.

Requerimientos

• Educación mínima: Universidad
• 1 año de experiencia
• Idiomas: Inglés

Palabras clave: calidad, quality, qa, ingeniero, engineers, ingeniera, ing, engineer

Hace 3 horas (actualizada)

Acerca de Manpower Costa Rica

Empresa Líder en Soluciones de Recursos Humanos.