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R&D Quality Engineer, ISO9001, ISO13485, Healthcare - Ireland
Eingestellt von Blue Personnel Ltd
Gesuchte Skills: Design, Engineer
Projektbeschreibung
R&D Quality Engineer - Ireland
R&D Quality Engineer required to work onsite in Ireland to take responsibility for the support of the Design Control Process within BCII (R&D and Packaging Development)
Responsibilities:
* Review projects at each gate of the Design Control Process and ensure compliant closure of DHF's
* Act as FMEA facilitator
* Support of System integration and Packaging Development
* Review requests put on R&D from other technical areas under regulatory aspects
* Conduct Internal Audits to ensure compliance of Technical Department (R&D technical areas, CSU, Packaging Development and System Integration) with ISO13485 and FDA quality requirements
* Training R&D technical staff on QSR/IVD requirements
* Training staff on Design Control procedures
* Aid in updating all Design Control and R&D Procedures/systems to ensure compliance with regulation (FDA/ISO and IVDD)
* Completion of Post Market Surveillance reports
The successful candidate will have
* Experience in a highly regulated (FDA desirable) healthcare or related environment
* Knowledge of GMP/Quality Standards - FDA - particularly Design Control requirements, ISO9001, ISO13485, IVDD
* Excellent planning, organisational and interpersonal skills
Blue Personnel Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.
Applications will be considered based only on skills and ability and will not discriminate on any grounds
R&D Quality Engineer required to work onsite in Ireland to take responsibility for the support of the Design Control Process within BCII (R&D and Packaging Development)
Responsibilities:
* Review projects at each gate of the Design Control Process and ensure compliant closure of DHF's
* Act as FMEA facilitator
* Support of System integration and Packaging Development
* Review requests put on R&D from other technical areas under regulatory aspects
* Conduct Internal Audits to ensure compliance of Technical Department (R&D technical areas, CSU, Packaging Development and System Integration) with ISO13485 and FDA quality requirements
* Training R&D technical staff on QSR/IVD requirements
* Training staff on Design Control procedures
* Aid in updating all Design Control and R&D Procedures/systems to ensure compliance with regulation (FDA/ISO and IVDD)
* Completion of Post Market Surveillance reports
The successful candidate will have
* Experience in a highly regulated (FDA desirable) healthcare or related environment
* Knowledge of GMP/Quality Standards - FDA - particularly Design Control requirements, ISO9001, ISO13485, IVDD
* Excellent planning, organisational and interpersonal skills
Blue Personnel Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.
Applications will be considered based only on skills and ability and will not discriminate on any grounds
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik