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Sr Quality Engineer - Commercial Quality
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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