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Senior Quality Engineer at CooperCompanies

Trumbull, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality management systems, FDA guidance, 21 CFR Part 820, ISO 13485:2016, MDSAP, Process validation, CAPA, Nonconformance management, Change control, Regulatory audits, Data analysis, Problem-solving, Negotiation, Microsoft Office, Quality assurance, Audit program management

Industry

Medical Equipment Manufacturing

Description

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 [http://www.coopersurgical.com]. Work location: Trumbull, CT (on-site) Scope: The Quality Engineer Sr will develop, maintain, and improve the Trumbull Quality Management System to ensure compliance with all relevant international standards and business requirements: FDA guidance, 21 CFR Part 820, ISO 13485:2016, MDSAP and others as applicable. This position will also provide overall quality assurance leadership in the production of Cooper Surgical products and drive the operational quality culture at the manufacturing process level. Job Summary: The Quality Engineer Sr will be responsible for ensuring the highest standards of quality throughout our organization and provide strategic thinking with a deep understanding of quality management systems, change control processes, and a proven track record of implementing and maintaining robust quality processes.

Responsibilities

The Senior Quality Engineer will develop and maintain the Quality Management System to ensure compliance with international standards and FDA regulations. They will also provide quality assurance leadership in production and drive the operational quality culture at the manufacturing level.