Senior Supervisor, Quality Engineering

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 Senior Supervisor, Quality Engineering is responsible for providing strategic oversight and leadership of Quality Management System (QMS) processes, including investigations, nonconformance management, CAPA, and compliance activities in accordance with applicable U.S. and international regulatory requirements (e.g., 21 CFR Parts 210, 211, 820, and ISO 13485). This role ensures consistent, compliant, and risk-based execution of quality processes through effective application of investigation methodologies, root cause analysis, and risk management principles, and is accountable for process quality, prioritization, escalation decisions, and inspection readiness, driving cross-functional alignment and continuous improvement to support product quality, regulatory compliance, and patient safety.

Job Summary: 

The Senior Supervisor, Quality Engineering oversees and directs key quality system processes, ensuring timely, thorough, and compliant handling of quality events, including deviations, nonconformances, complaints, and audit observations, and is responsible for the intake, review, prioritization, assignment, and approval of investigations and quality records, as well as evaluating outcomes to determine appropriate escalation actions such as CAPA initiation, risk assessments, trend analysis, and regulatory reporting. The Senior Supervisor leads cross-functional collaboration with Quality, Regulatory Affairs, Manufacturing, R&D, Supply Chain, and external partners to drive effective issue resolution, risk mitigation, and process alignment. This role ensures verification of investigation conclusions and corrective actions, maintains the integrity of quality system documentation, and supports audit readiness. This role also coaches and mentors QA personnel, promotes consistent quality practices, and serves as a subject matter expert during internal and external audits and inspections, and helps develop and present quality metrics and trending analyses to leadership and drive continuous improvement of QMS processes based on data insights, risk signals, and evolving regulatory expectations.

• Provides strategic oversight of core Quality Management System processes, including investigations, complaints, CAPA, and audit observations, ensuring consistent application of risk-based methodologies and root cause analysis tools. 
• Reviews, triages, and assigns quality events to ensure appropriate prioritization and timely, compliant resolution, with consideration of product quality, patient safety, and regulatory risk. 
• Evaluates and approves investigation outcomes and associated risk assessments to determine the need for escalation such as CAPA, trend analysis, or regulatory reporting, ensuring risks are properly identified and mitigated. 
• Leads and facilitates cross-functional discussions and decision-making forums to drive timely issue resolution and alignment across Quality, Regulatory, Manufacturing, R&D, Supply Chain, and external partners. 
• Oversees verification of investigation conclusions and effectiveness of corrective and preventive actions through follow-up activities and effectiveness checks. 
• Coaches, mentors, and provides technical guidance to QA personnel to ensure consistent execution of quality processes and regulatory compliance. 
• Reviews and approves quality records (e.g., deviations, complaints, CAPAs) to ensure completeness, accuracy, and compliance with internal procedures and regula