Senior Quality Engineer
About this role
Senior Quality Engineer
Duties: Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Combination Product Operations activities; Ensure that the Quality Systems in place for Amgen products are appropriately scoped and followed; Provide quality oversight for device and combination-product related design controls per FDA CFR 820.30 and 21 CFR Part 4, CAPA, RCA, Change Controls, product complaints investigations, and other assignments as given; Manage low to moderate complexity programs such as automating team activities and combination product commercial quality oversight with minimal supervision; Collaborate with the Senior Manager Quality Engineering, COPQ Commercial and be a liaison with other groups in Amgen as needed to support programs; and Provide quality guidance for documentation…
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