Description

ESSENTIAL FUNCTIONS:

The role provides input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to the following: Annual Product Review, Process control, Change Control, Validation, Product complaints, Audits, Internal Audits, Supplier Quality, OOS, CAPA and identification/recommendations for continuous improvement opportunities (internal/external). The Sr. Quality Engineer applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity.

Additional functional requirements: