Job Description

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.

• Ensure that all associated documentation, such as production records, quality controls, and tests, is complete and meets standards and release the Finished goods.

• Support the Quality Control department operations in adherence to FDA 21 CFR, ISO 13485, GMPs, and other applicable regulations.

• Support internal and external audits related to product release, as well as support root cause investigations or quality figures as appropriate.

• Support projects, ideas, and continuous improvement initiatives focused on their work area.

• Notify the designated supervisor/quality engineer when inspection results exceed acceptable limits and/or report significant quality incidents or inconsistencies in the documentation process.

• Perform other tasks or assignments as required by management or the assigned supervisor.

• Contribute with the certification and training in the DHR Release area.

Qualifications Knowledge, Skills, and Abilities:

• Proficiency in using systems and data packages such as Microsoft Office and Dynamics 365.

• Ability to review and understand written instructions, including blueprints, specifications, and method sheets.

• Attention to detail.

Work Environment:

• Required to spend prolonged periods in front of a computer.

Experience:

• 3 years of experience in Quality Assurance or Quality Control.

Education:

• Technical Degree in Quality or related field is required.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com