Quality Engineer I
About The Position
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). The Quality Engineer I supports the implementation, execution, 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 applicable elements of 21 CFR Part 820. This role provides foundational support for quality system activities including investigations, CAPA, Change Control, documentation control, and data integrity, and works under direction of senior quality staff and contributes to compliant operations, timely issue resolution, and inspection readiness while escalating complex or high-risk issues appropriately. The Quality Engineer I facilitates regulatory compliance at the North Tonawanda, NY facility pertaining to 21 CFR Parts 210, 211, and applicable sections of 820. The role supports closure and monitoring of internal investigations, contributes to effectiveness and sustainability of the site’s QMS, and helps ensure product quality, regulatory compliance, inspection readiness, and data integrity. This role performs quality engineering activities of basic to moderate complexity under established procedures and guidance from senior quality staff, while continuing to develop technical, regulatory, and critical-thinking proficiency in a regulated manufacturing environment.
Requirements
- Understanding of applicable FDA regulations and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210, 211, and applicable elements of 21 CFR Part 820.
- Foundational support for quality system activities including investigations, CAPA, Change Control, documentation control, and data integrity.
- Ability to work under direction of senior quality staff.
- Ability to contribute to compliant operations, timely issue resolution, and inspection readiness.
- Ability to escalate complex or high-risk issues appropriately.
- Ability to facilitate regulatory compliance.
- Ability to support closure and monitoring of internal investigations.
- Ability to contribute to the effectiveness and sustainability of the site’s QMS.
- Ability to help ensure product quality, regulatory compliance, inspection readiness, and data integrity.
- Ability to perform quality engineering activities of basic to moderate complexity under established procedures and guidance from senior quality staff.
- Willingness to develop technical, regulatory, and critical-thinking proficiency in a regulated manufacturing environment.
Responsibilities
- Supports the implementation, execution, and maintenance of the site Quality Management System (QMS).
- Ensures compliance with applicable FDA regulations and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210, 211, and applicable elements of 21 CFR Part 820.
- Provides foundational support for quality system activities including investigations, CAPA, Change Control, documentation control, and data integrity.
- Works under the direction of senior quality staff.
- Contributes to compliant operations, timely issue resolution, and inspection readiness.
- Escalates complex or high-risk issues appropriately.
- Facilitates regulatory compliance.
- Supports closure and monitoring of internal investigations.
- Contributes to the effectiveness and sustainability of the site’s QMS.
- Helps ensure product quality, regulatory compliance, inspection readiness, and data integrity.
- Performs quality engineering activities of basic to moderate complexity under established procedures and guidance from senior quality staff.
- Continues to develop technical, regulatory, and critical-thinking proficiency in a regulated manufacturing environment.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
