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Primary job duties and responsibilities include but are not limited to:

Supervision and oversight of other Quality Assurance team members
Oversees InGeneron Quality Management System processes and ensures compliance
Reports Quality related questions, trends, and concerns to Executive Management
Works with production, product engineering, and contract manufacturers in the management of cGMP product design and development, manufacturing, packaging, labeling, and distribution to ensure the quality and safety of InGeneron product
Works with Regulatory professionals to ensure compliance of systems and products
Review and approval or rejection of documentation including, but not limited to:

Product and design specifications,
manufacturing batch/device history records,
test protocols
test records,
test results,
labeling,
deviations,
supplier qualification

Following applicable regulatory and …