Quality Engineering Advisor
MedImmune - Gaithersburg, MD

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MedImmune currently has an opening for a Quality Engineering Advisor based at its headquarters in Gaithersburg, Maryland. The Quality Engineering Advisor is responsible for Quality Engineering functions in site Quality Assurance. Participates in the development of new systems/operations required to run manufacturing facilities. Responsible for ensuring that Development and Operations for Medical Devices and Combination Products meet current GMP requirements.
Manages project plans to assure timely completion of projects. Supports the evaluation and lifecycle of aspects of change management. Investigates and assesses the impact of deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems. Identifies root causes and recommends/implements corrective actions to prevent recurrence. Performs trend analysis to monitor quality system performance. Performs audits to resolve problems and to ensure compliance with SOP and regulatory requirements.


At least 5 years of experience in a medical device related industry, with a preference of 8 years of medical device experience, preferably with hands on operational experience.

B.S. Engineering or Technical Field.

About this company
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MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...