Quality Engineering Specialist

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.

• Support the implementation and maintenance of risk‑based quality processes to ensure compliance with 21 CFR Parts 210 and 211 under the guidance of senior quality staff.
• Assist in the development, implementation, and maintenance of the site Quality Management System (QMS) in accordance with cGMP requirements, FDA regulations, and internal procedures.
• Execute internal investigations related to deviations, environmental excursions, out‑of‑specification (OOS), and out‑of‑trend (OOT) events in a timely and compliant manner, with appropriate oversight.
• Apply structured root cause analysis tools to support identification of contributing and root causes of nonconformances.
• Support the development and tracking of Corrective and Preventive Actions (CAPAs), including documentation and effectiveness checks, to ensure resolution of quality issues.

• Support the site Change Control process by reviewing change requests for completeness, accuracy, and compliance with cGMP requirements, and by assisting in impact assessments, documentation, and timely closure under the guidance of senior quality staff.

• Collaborate with cross‑functional teams (Manufacturing, Engineering, Validation, Regulatory, and Quality) to support the execution and timely closure of investigations, corrective actions, and Change Control activities in accordance with cGMP requirements.

• Ensure quality documentation is accurate, complete, and compliant with cGMP documentation practices.
• Participate in quality meetings and forums to communicate investigation status and support continuous improvement initiatives.
• Provide support during internal, customer, and regulatory audits, including document preparation and response support.
• Contribute to continuous improvement activities related to QMS processes, procedures, and quality systems.
• Perform other duties as assigned.

Travel: this position may require 10-20% domestic and/or international travel. 

Knowledge, Skills and Abilities:

• Foundational knowledge of FDA regulations and c