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Sr Quality Engineer - Commercial Quality

REMOTE, CA 00000

Posted: 11/01/2024 Employment Type: Contract Job Category: Engineering Job Number: 615742 Is job remote?: Yes Country: United States

Job Description


Target PR Range: 33-43/hr
*Depending on experience

Standard business hours (8 AM -5 PM)

* 5+ years of experience pharma, biotech, medical device
* Bachelors Degree in Engineering or similar


As a member of Commercial Quality group for drug delivery systems, the Sr Quality Engineer – Commercial Quality will provide quality engineering support for the product life cycle management and design control systems in the maintenance of commercialized drug delivery devices, combination products, and non-combination products.

Responsibilities include participation in the implementation of Design controls per FDA CFR 820.30, Corrective and Preventive action projects, documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
This person ensures that Quality Systems identified for combination products are appropriate and compliant for commercial activities. Manages low to moderate complexity programs with minimal supervision.

Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates in non-design control investigations on an as needed basis.

This position reports to the Sr Manager Quality Engineering, CPOQ Commercial and is a liaison with CPOQ Development.

*CO/NYC candidates might not be considered
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