Senior Quality Engineer

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 Sr is responsible for owning the Change Control program and providing QA oversight of validation, equipment lifecycle management, and risk management systems. This role ensures compliance with FDA regulations and current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210, 211, applicable elements of 21 CFR Part 820, and relevant ISO standards (e.g., ISO 13485), while embedding risk-based thinking across all quality system processes and site operations, and leads the application of formal risk management principles across the Quality Management System (QMS), ensuring business decisions, process improvements, and quality actions are prioritized, justified, and executed based on scientific, data-driven risk assessment.

Job Summary: 

The Quality Engineer Sr provides site-wide leadership in risk-based quality engineering, with primary accountability for the Change Control program, QA oversight of validation and equipment management, and the integration of risk management into all quality and operational processes at the North Tonawanda, NY facility. This role ensures that all changes, validation activities, and quality systems are executed using robust risk assessment methodologies, enabling compliant, efficient, and inspection-ready operations, and works extensively with cross-functional teams to support new and improved processes, ensuring that risks are proactively identified, evaluated, controlled, and continuously monitored. This role also leads and supports supplier quality, investigations, CAPA, audit response, and inspection readiness, while contributing to site training and quality culture development.

• Own and govern the site Change Control program, ensuring all changes are initiated, risk-assessed, approved, implemented, and closed in compliance with regulatory and internal requirements; drive continuous improvement in effectiveness, cycle time, and compliance metrics.
• Lead and embed risk management practices across the site, applying ICH Q9 principles to Change Control, validation, investigations, CAPA, and supplier quality; facilitate formal risk assessments (e.g., FMEA), ensure risk-based decision-making, and proactively identify and mitigate systemic risks.
• Provide QA oversight for validation and equipment lifecycle management, including equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and CSV; ensure all activities are risk-based, compliant, and aligned with cGMP and data integrity requirements.
• Partner cross-functionally with Engineering, Manufacturing, Validation, Regulatory, Supply Chain, and other stakeholders to support new and improved processes, ensuring quality-by-design and risk-based principles are embedded in process design, changes, and technology transfers.
• Perform complex investigations and CAPA, ensuring robust root cause analysis, risk prioritization, and implementation of effective, sustainable corrective and preventive actions that address systemic issues.
• Support the site supplier quality program, including supplier-related investigations, CAPA, change evaluations, risk assessments, and audit follow-up activities to ensure supplier compliance and performance.
• Support audit and inspection activities, including internal, supplier, and regulatory audits; serve as a key QA representative during inspections, ensure effective response to audit observations, and maintain a continuous state of inspection readiness.
• Review and approve complex quality documentation, ensuring accuracy, completeness, and co