Quality Engineer I

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments.

Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.

Learn more at www.coopersurgical.com .

Work location: North Tonawanda, NY (on-site)

Scope:

The responsibility of a Quality Engineer is to ensure 21 CFR parts 210, 211 and 820 Compliance among within the manufacturing process.

Job Summary:

CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare.

The responsibility of the Quality Engineer I is to facilitate regulatory compliance at the North Tonawanda, NY facility pertaining to 21 CFR parts 210, 211 and 820.

In this role, the Quality Engineer I will be primarily responsible for the closure and monitoring of internal investigations related to product complaints as well as contributing to efficacy of the site's Quality Management System (QMS), as needed.