To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99682012_QA_Engineer.html
To see other op****tunities, please visit http://sqa.fyicenter.com
Date: 17-Jul-2008
QA Engineer
=95 Stand as independent QA reviewer along NPI
=95 Stand as independent QA reviewer of Customs dossiers.
=95 Complete appropriate review of customs DHF/DMR.
=95 Complete final QA release of customs.
=95 Train US team to applicable regulations, QA system/procedures, QA
requirements.
=95 Stand as local compliance officer.
=95 Complete internal audits according internal audit plan. (Under QC
manager's supervision).
=95 Conduct Internal audits according to plan.
=95 Complete Vendors audit according to plan.
=95 Enhance monitoring/re****ting on QA/Compliance on activity in the US
Business Center by enhancing relevent metrics.
=95 Complete QA release of products under ERP system.
=95 Provide QA sup****t and monitoring of prototype shop and customs
shop.
=95 Guarantee appropriate Management of the inspection means used in the
prototype/customs shop.
=95 Trigger required containment action (e.g Product Hold) to mitigate
serious/severe safety or compliance issue.
=95 Trigger Corrective/Preventive action to maange detected non-
conformances.
=95 Act as a CAPA specialist. Qualifications/Work Experience The ideal
candidate for this position will have the following qualifications.
=95 Knowledge of regulations/standards/directive applicable to spinal
implants and instruments (ISO13485, 21CFR820, 93/42/CE, cGMPs)
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
