Quality Engineering Specialist at CooperCompanies

North Tonawanda, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

13 May, 26

Salary

90000.0

Posted On

12 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA Regulations, Good Manufacturing Practices, Quality Management System, Quality Investigations, Root Cause Analysis, Analytical Problem-Solving, Documentation Control, Change Control, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Continuous Improvement, Regulatory Audits, Attention to Detail, Data Integrity

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. Work location: North Tonawanda, NY (on-site) Scope: The Quality Engineering Specialist supports the implementation and maintenance of the site Quality Management System (QMS) at the North Tonawanda, NY facility to ensure compliance with applicable FDA regulations and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210, 211, and 820. This includes supporting quality system activities related to internal investigations, CAPA, Change Control, documentation control, and continuous improvement, and interfacing cross‑functionally with Manufacturing, Engineering, Validation, Regulatory, and Quality to support compliant operations, timely issue resolutions, and inspection readiness. Job Summary: The Quality Engineering Specialist is responsible for facilitating regulatory compliance at the North Tonawanda, NY facility pertaining to 21 CFR parts 210, 211 and 820, as well as the closure and monitoring of internal investigations, contributing to efficacy of the site’s Quality Management System (QMS) as needed. The Quality Engineering Specialist contributes to maintaining product quality, regulatory compliance, and data integrity while developing technical and regulatory proficiency within a regulated manufacturing environment.

Responsibilities

The Quality Engineering Specialist is responsible for facilitating regulatory compliance at the North Tonawanda facility and supporting the Quality Management System. This includes managing internal investigations, CAPA, Change Control, and ensuring inspection readiness.