Quality Engineer I

CooperCompanies•North Tonawanda, NY

2d•Onsite

About The Position

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

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.
0+ years experience working in manufacturing environment preferably within pharmaceutical or medical device related field.
Bachelor’s degree in Health, Engineering or Science preferred or equivalent work experience.

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.