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Gracias por aplicar al anuncio de empleo Senior quality engineer, en Confluent medical technologies
Este anuncio de empleo ya no está disponible. Conoce todos los anuncios de empleo que tenemos publicados.
Salario confidencial CRC
Costa Rica Toda Costa Rica Toda Costa Rica Toda Costa Rica
Publicado 17 May 2017 2017-5-17 16/07/2017
The person in this position will participate in Medical Device process transfers to Costa Rica, also he/she will apply Quality Engineering tools, Quality Management Standards and Regulations, including ISO 13485 and CFR 21 Part 820, Six Sigma tools to current processes to maintain and improve quality. Among his/her duties, the following are included:
- Write and execute Validation Strategy Protocols, implement IQ, OQ, PQ, TMV, software and manufacturing validation, etc.
- Develop FMEAs, Manufacturing Quality Plans, Inspection Plans using adequate sampling plans to mitigate risk.
- Deals with NCRs, CAPAs, SCARs, Action Items, Customer Complaints
- Generate quality reports and metrics for Management.
- Conducts process audits.
- Generates and revises quality system documents through ECO and DCOs.
- Other tasks related to the position.
This position requires a BS in a related engineering discipline; and +5 years of experience in the Medical Device Industry.
At least 3 years of experience in the medical device transfers.
Training in ISO 13458 and/or CFR Part 820.
Experience writing Validation Strategies and protocols.
Good skills in statistics and quality engineering.
Fluent in English (above 90%).
CQE or Six Sigma training would be a plus.
Experience with EO and/or E beam sterilization would be a plus.
Profesional
Bachillerato universitario
Ingeniería Eléctrica - Electromecánica Electrónica y Mecatrónica
Ingeniería Industrial
Ingeniería Mecánica
Ingenierías Otras
Ingeniería Química
5 años de experiencia
Ingeniero
1 Vacante
This position requires a BS in a related engineering discipline; and +5 years of experience in the Medical Device Industry.
At least 3 years of experience in the medical device transfers.
Training in ISO 13458 and/or CFR Part 820.
Experience writing Validation Strategies and protocols.
Good skills in statistics and quality engineering.
Fluent in English (above 90%).
CQE or Six Sigma training would be a plus.
Experience with EO and/or E beam sterilization would be a plus.
Competencias para la vacante
Profesional
Ingeniero
Bachillerato universitario
Equipo medico
5 años de experiencia
Contrato Indefinido
730261
Gracias por aplicar al anuncio de empleo Senior quality engineer, en Confluent medical technologies
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