Descripción y detalle de las actividades
- Purpose of the Job: To make sure that product inspections are performed in compliance with the established procedures and instructions and product release is performed in a timely manner according with the results. Can coordinate and support NC process, investigation and corrective actions implementation. Oversee environmental monitoring activities in coordination with local and external departments. Key Responsibilities: -Coordinates environmental test logistics with Manufacturing, Purchasing, and external testing labs. -Collects and prepares samples for quarterly testing and reporting of product bioburden, bacterial endotoxin and particulates. -Make sure environmental testing results is received in Valencia, CA. -Assists in the disposition and corrective action, if necessary, of non-conformances related to environmental monitoring in accordance to AB LLC (Valencia, CA plant) communication on testing reports. -Perform supervisory activities to quality inspectors -Coordinates quality inspectors/technician training -Support Quality engineers on day to day activities, internal investigation and NC material control.
-Can provide training on quality topics during New Hire Orientation -Can elaborate trend reports for Management Review -Can perform viable counts when necessary.
Experiência y requisitos
- Bachelor Degree in engineering -2+ years of relevant experience in medical device environment -Proficient verbal and written communication skills -Excellent interpersonal skills -Experience with GMP and GDP -English 80% - Proficient in Microsoft Word, Excel, and Outlook Additional Remarks: In order to accommodate production schedules, some occasional weekend work may be required on a rotating basis. Desirable: Experience with environmental monitoring Knowledge on ISO 14644 Visa B1/B2 preferently
Beneficios
- Incentivos de acuerdo a la LFT
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Mixto
**Jornada** Tiempo Completo
**Estudios** Carrera con título profesional
**Inglés**Hablado: 80%, Escrito: 80%
**Disponibilidad p. viajar** No