TECHNOLOGY TRANSFER ENGINEER
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Job Reference Number |
13452041 |
Client ID: |
RI/CJ08640-. |
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Posted On: |
Jun 11 2009 |
Location: |
CORK |
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Job Type: |
Permanent
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Salary: |
NEGOTIABLE |
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Reporting to the QA Technical Leader the Technology Transfer Engineer shall lead from a Quality Equipment Engineering perspective.
Responsibilities:
Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on site production and purchased for resale goods. Compile and execute validation protocols for new product/processes and software. Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity. Lead Design for Inspection activities for all New Product Development Lead QA input in Design for Manufacture activities on site. Ensure correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues. Ensure compliance with all Documented Quality system, as per SEP 180 i.e. FDA QSR's and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
Experience:
A degree level or similar qualification in mechanical or industrial engineering, combined with a minimum of 5 years experience in a quality role within a regulated industry. Proven ability to successfully introduce new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
Excellent package on offer to the right candidate - For additional information please contact Anne on 021-4809118 or email anne.duggan@collinsmcnicholas.ie
