US: QA Engineer (Temp)
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please visit http://sqa.fyicenter.com
QA Engineer (Temp)
Review and approves validation protocols for product and process changes.
Review and approve revision changes to DOPs, manufacturing process, components, software and labeling.
Ensure failure investigations are performed and well documented for non-conforming materials and products.
Establish and maintain database to track root cause, disposition, and cost for non-conforming material.
Review customer complaints and analyze data for trends.
Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions.
Work with management to devise and implement quality strategies and policies.
Conduct internal/external audits to assure compliance to quality and regulatory requirements.
Supervise technician in the inspection, batch record review and release of products.
Provide guidance and training to other employees and QA Technicians as required.
Degree in Science, Engineering or equivalent.
Min 2 years QA experience, preferably in pharmaceutical / biotech industries.
Working knowledge of ISO 13485 and QSR will be most advantageous.
Proficient in the use of quality tools (eg. Trend, regression charts) to present and articulate identified issues.
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Team SQAFYI - Software QA Resource FYI