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.

Work location: North Tonawanda, NY (on-site)

About the Role

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. The role 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.

Responsibilities

• 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 regulatory requirements.
• Ensures maintenance of complete, accurate, and traceable quality system documentation within designated systems; monitors progress and drives timely escalation when needed.
• Maintains inspection readiness by ensuring documentation is clear, objective, contemporaneous, and audit-ready.
• Supports and contributes to regulatory actions as needed (e.g., responses to inspections, recalls, or field corrections).
• Develops, reviews, and presents quality metrics and trending analyses to leadership to support oversight and continuous improvement initiatives.
• Serves as a subject matter expert during internal and external audits and inspections related to QMS processes and regulatory compliance.
• Drives continuous improvement of quality systems, processes, tools, and practices based on trends, audit findings, and evolving regulatory expectations.
• Performs other duties as assigned.

Travel: This position may require up to 5% domestic and/or international travel.

Requirements

• 5+ years of experience in the pharmaceutical, medical device, or combination product industry, with demonstrated responsibility for product complaint handling, post-market surveillance, CAPA processes, and regulatory compliance within a regulated environment.
• 2+ years of oversight of complaint investigation activities, mentoring and coaching technical staff, workload prioritization, and accountability for investigation quality, timelines, and escalation decisions.
• Bachelor’s degree in a Health, Engineering or Science field required.

Skills

• Advanced knowledge of Quality Management Systems and oversight of investigations, complaints, nonconformances, and CAPA processes within regulated environments.
• Strong risk assessment and decision-making capabilities, including the ability to evaluate data, assess impact, and determine appropriate escalation pathways.
• Proven ability to review, approve, and defend quality records and decisions with strong scientific and regulatory rationale.
• Demonstrated leadership and supervisory skills, including coaching, mentoring, and developing technical teams.
• Strong cross-functional collaboration and communication skills.
• Excellent analytical and problem-solving abilities, including trend identification and proactive risk mitigation.
• Experience managing controlled documentation and electronic quality systems to ensure data integrity and inspection readiness.
• Strong written communication skills with the ability to produce clear, concise, and audit-defensible documentation.
• Effective organizational and prioritization skills to manage multiple quality processes and deadlines.
• In-depth understanding of audit and inspection readiness and ability to support regulatory inspections.
• Continuous improvement mindset with experience driving process enhancements.

Work Environment

Office/Production/Clean Room/Warehouse Environment which may require long periods of sitting, standing, or getting up and down throughout the day. Occasionally lift to 35 pounds.

Benefits

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. Benefits include medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

Pay

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $82,000.00 - $115,000.00 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.