Job 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 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.
Job Summary:
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.
Responsibilities
- Support the execution and maintenance of QMS processes, including deviations, investigations, CAPA, and Change Control, in compliance with cGMP and regulatory requirements.
- Assist in internal investigations by gathering data, documenting findings, and supporting follow-up activities under guidance from senior quality staff.
- Apply basic root cause analysis tools (e.g., 5 Whys, fishbone) to support investigation activities with oversight.
- Support the development and tracking of CAPAs, including documentation, action follow-up, and evidence collection to ensure timely completion.
- Assist with Change Control activities, including preparation of documentation and support for impact assessments under supervision.
- Review and ensure quality documentation is accurate, complete, and compliant with cGMP documentation practices and data integrity requirements.
- Monitor and report quality system metrics (e.g., deviations, CAPA, Change Control aging) and escalate potential compliance concerns.
- Collaborate with cross-functional teams (Manufacturing, Engineering, Validation, Regulatory, Quality) to support quality system activities and issue resolution.
- Provide support during internal, customer, and regulatory audits, including document retrieval and follow-up actions under guidance.
- Assist with inspection readiness activities, including document organization, mock audits, and identification of potential gaps.
- Contribute to continuous improvement initiatives focused on documentation quality, process efficiency, and compliance effectiveness.
- Perform other duties as assigned.
Travel:
This position may require 5-10% domestic and/or international travel.
Qualifications
Knowledge, Skills and Abilities:
- Working knowledge of FDA regulations and cGMP requirements, including 21 CFR Parts 210 and 211, with the ability to apply requirements within routine quality system activities.
- Developing proficiency in Quality Management System (QMS) processes, including deviations, investigations, CAPA, and Change Control, and their role in maintaining compliance.
- Experience supporting quality investigations, including data gathering, documentation, and contributing to root cause identification under guidance.
- Ability to apply structured problem-solving and root cause analysis tools (e.g., 5 Whys, fishbone) with increasing independence.
- Experience supporting CAPA development, documentation, and tracking, ensuring timely completion of assigned actions.
- Strong attention to detail with demonstrated ability to generate, review, and maintain accurate, compliant cGMP documentation aligned with data integrity principles.
- Effective written and verbal communication skills, with ability to clearly document findings and collaborate cross-functionally.
- Solid organizational and time management skills, with the ability to prioritize tasks, follow procedures, and meet deadlines in a regulated environment.
- Demonstrated willingness to learn and grow, with the ability to apply feedback to improve technical, regulatory, and problem-solving capabilities.
- Ability to identify potential compliance risks, raise concerns, and escalate issues appropriately to ensure timely resolution.
Work Environment:
- Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
- Occasionally lift to 35 pounds.
Experience:
- 0+ years experience working in manufacturing environment preferably within pharmaceutical or medical device related field.
Education:
- Bachelor’s degree in Health, Engineering or Science preferred or equivalent work experience.
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Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $60,000.00 - $80,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.