2 publicaciones de empleo destacadas de test engineer en tijuana, bcn (¡Están contratando!)

Environmental and Sterilization Quality Engineer
Centerpiece S. de R.L de C. V. —Rosarito, B.C.
- $1,200 a $1,900 por día
- Tiempo completo
- Inglés
- Licenciatura
- Primeros auxilios
- Seguro de vida
Postulación rápida
6h
Sr. Full Stack Software Engineer
North American Production Sharing —Tijuana, B.C.
- Azure
- Administración de personal
- Informática
Postulación rápida
8d

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Environmental and Sterilization Quality Engineer

Centerpiece S. de R.L de C. V.
Rosarito, B.C.

Postulación rápida

Información del empleo

Tiempo completo
$1,200 a $1,900 por día
Hace 6 horas

Beneficios

Seguro de gastos médicos mayores
Vales de despensa
Estacionamiento para empleados
Seguro de vida
Estacionamiento de la empresa

Cualificaciones

Inglés
Ingeniería
Licenciatura
Primeros auxilios
Experiencia en manufactura

Descripción completa del empleo

Develop and Coordinate Environmental and Sterilization Plans with full implementation of new and modified products
Environmental and Sterilization Validations
File, update and maintain Environmental and Sterilization records in accordance with current US and foreign regulations for Facility registrations, certification and licenses
Maintain and organize appropriate Environmental and Sterilization records to demonstrate compliance with applicable regulations
Perform Environmental and Sterilization contractor monitoring and audits.
Continuously improve Sterilization and Environmental processes and practices
Generate, coordinate and follow up any CAPA, NCMR or Complaint related to
Sterilization and Environmental activities.
Develop, implement and maintain the Environmental and Sterilization sampling plans
that apply to Centerpiece for the activities that occur to be in compliance with international regulation.
Serve as a safety administrator.
Customers communication on any item related to Sterilization or Environmental issues.
Other tasks related to the organization requested by Direct Supervisor.
Manage sterilization service provider to ensure they are complying to the latest regulatory requirements and current governed standard.

JOB RESPONSIBILITIES:

Manage sterilization service provider to ensure they are complying to the latest regulatory requirements and current governed standard.
Supervise and support the internal sterilization process to ensure the latest regulatory requirements and current governed standard is adhered.
Manage the sterilization validation process including preparing and reviewing of protocol & report.
Supervision and organization of the environmental control to ensure the cleanroom / controlled room is working within specification.
Supervision and organization of the hygiene practices and microbiological control to ensure the practice is conform to requirement.
Supervise the investigation and action for the anomaly of the microbiological issues.
Supervise and manage the outsourced testing laboratory to ensure the test method is comply to requirement.
Leading/supporting non-conformance investigation activities derived from internal/external including risk assessment, root cause analysis, implementing corrective & preventive action, etc.
Identify and initiate improvement activities through analysis of data from quality records.
Ensure the periodic validation review is conducted in timely manner.
Support in internal and external audit process.
Execute supplier audit including generating audit plan, preparing audit report, follow up with supplier reply, etc.
Work with Supply Chain to ensure the Supplier Corrective Action Report issued to supplier is closed in timely manner.
Assist and report all microbiological and sterilization related matters to superior.

JOB REQUIREMENTS:

Candidate must possess at least Degree in Microbiology or science related field or equivalent,
At least 2 years’ working experience in handing microbiological related task & sterilization process in a manufacturing industry, preferably in Medical Device industry.
Preferably candidate with good knowledge of ISO 13485, GMP and FDA 21 CFR Part.
Have similar experience working in cleanroom environment.
Able to work in a team and under minimum supervision.
Strong interpersonal, analytical and problem-solving skills.
Initiative, proactive, resourceful, able to multi-tasks and work independently.
Good written and verbal communication skills in English

Tipo de puesto: Tiempo completo

Sueldo: $1,200.00 - $1,900.00 al día

Beneficios:

Estacionamiento de la empresa
Seguro de gastos médicos mayores
Seguro de vida
Vales de despensa

Puede trasladarse/mudarse:

22706, Rosarito, B.C.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)

Escolaridad:

Licenciatura terminada (Deseable)

Experiencia:

Micro y procesos de esterilización en una industria medica: 2 años (Obligatorio)
ISO 13485: 2 años (Obligatorio)
GMP y FDA 21 CFR Part.: 2 años (Obligatorio)

Idioma:

Inglés (Obligatorio)

Lugar de trabajo: Empleo presencial

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Environmental and Sterilization Quality Engineer

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