US-NJ-Allendale:QA Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 17-Jul-2008

QA Engineer

• Stand as independent QA reviewer along NPI

• Stand as independent QA reviewer of Customs dossiers.

• Complete appropriate review of customs DHF/DMR.

• Complete final QA release of customs.

• Train US team to applicable regulations, QA system/procedures, QA requirements.

• Stand as local compliance officer.

• Complete internal audits according internal audit plan. (Under QC manager's supervision).

• Conduct Internal audits according to plan.

• Complete Vendors audit according to plan.

• Enhance monitoring/reporting on QA/Compliance on activity in the US Business Center by enhancing relevent metrics.

• Complete QA release of products under ERP system.

• Provide QA support and monitoring of prototype shop and customs shop.

• Guarantee appropriate Management of the inspection means used in the prototype/customs shop.

• Trigger required containment action (e.g Product Hold) to mitigate serious/severe safety or compliance issue.

• Trigger Corrective/Preventive action to maange detected non-conformances.

• Act as a CAPA specialist. Qualifications/Work Experience The ideal candidate for this position will have the following qualifications.

• Knowledge of regulations/standards/directive applicable to spinal implants and instruments (ISO13485, 21CFR820, 93/42/CE, cGMPs)

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com