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; Trumbull, CT; or Livingston, NJ (on-site)

Scope:

The Sr 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 Sr 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 Sr 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.

Essential Functions & Accountabilities:

• 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.
• Perform other duties as assigned.

Travel:

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

Qualifications

Knowledge, Skills and Abilities:

• 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.

Experience:

• 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.

Education:

• Bachelor’s degree in a Health, Engineering or Science field required.

#LI-KA1

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 $90,000.00 - $120,000.00 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.

• Provides strategic oversight of comprehensive, risk‑based product complaint investigations for combination drug‑device products, ensuring consistent application of appropriate investigation methodologies and root cause analysis tools across the Product Surveillance function.
• Reviews, triages, and assigns incoming product complaints to ensure investigations are prioritized appropriately and conducted in a timely, scientifically sound, and compliant manner, with thorough assessment of product performance, patient safety impact, and regulatory risk.
• Evaluates and approves investigation outcomes, including documented risk assessments, to determine the need for escalation such as CAPA initiation, Health Hazard Evaluations, trend analysis, and regulatory reporting, ensuring potential risks are accurately identified, justified, and effectively addressed.
• Leads and facilitates cross‑functional meetings and decision‑making forums to drive complaint resolution, post‑market risk evaluation, and data alignment, partnering with Quality, Regulatory, R&D, Manufacturing, Medical Affairs, Supply Chain, and external parties such as contract manufacturers and suppliers.
• Oversees verification of investigation conclusions and associated corrective and preventive actions through defined follow‑up activities, effectiveness checks, and milestone reviews, ensuring corrective actions address root causes and mitigate identified risks.
• Coaches, mentors, and provides technical guidance to Product Surveillance personnel, promoting consistent investigation quality, regulatory compliance, and professional development across the team.
• Reviews and approves product complaint investigations to ensure all investigation activities, root cause analyses, risk assessments, and follow‑up actions are completed in compliance with applicable regulatory requirements and internal procedures.
• Ensures the maintenance of complete, accurate, and traceable complaint and post‑market surveillance records within designated tracking systems and databases; monitors investigation progress and action item status and drives timely escalation when required.
• Ensures post‑market surveillance and complaint investigation documentation remains clear, objective, contemporaneous, and compliant, supporting inspection readiness, audit defensibility, and regulatory confidence.
• Escalates and contributes to field actions, including field alerts and recalls, based on investigational findings, ensuring alignment with regulatory requirements and internal escalation processes.
• Develops, reviews, and presents routine post‑market surveillance metrics, trending analyses, and risk signals to leadership to support oversight, decision‑making, and continuous improvement initiatives.
• Serves as a subject‑matter expert during internal and external audits and inspections related to complaint handling, post‑market surveillance, complaint CAPA escalation, and regulatory compliance for combination products.
• Drives continuous improvement of post‑market surveillance and Quality Management System processes, procedures, tools, and investigative practices based on complaint trends, investigation outcomes, risk signals, and evolving regulatory and industry expectations.
• Perform other duties as assigned.

Travel: This position may require 10% domestic and/or international travel.

Knowledge, Skills and Abilities:

• Advanced expertise in overseeing comprehensive, risk‑based product complaint investigations, including application of structured root cause analysis methodologies and evaluation of investigation quality for combination drug‑device products.
• Strong risk assessment and decision‑making skills, with the ability to interpret investigation data, assess patient safety and regulatory risk, and determine appropriate escalation pathways, including CAPA initiation, Health Hazard Evaluations, trend analysis, and regulatory reporting.
• Proven ability to review, approve, and defend complaint investigations and escalation decisions, ensuring scientific rigor, regulatory compliance, and alignment with business and patient safety objectives.
• Excellent leadership and supervisory skills, including the ability to coach, mentor, and provide technical guidance to Product Surveillance personnel to ensure consistent investigation practices and regulatory compliance.
• Highly effective cross‑functional communication and facilitation skills, enabling collaboration with Quality, Regulatory Affairs, R&D, Manufacturing, Medical Affairs, Supply Chain, and external partners to drive timely complaint resolution and risk mitigation.
• Strong analytical and problem‑solving capabilities, with the ability to evaluate trends, identify emerging post‑market risk signals, and recommend proactive quality and system improvements.
• Demonstrated proficiency in maintaining and overseeing controlled complaint and post‑market surveillance records, databases, and tracking tools to ensure accuracy, traceability, and inspection readiness.
• Exceptional written communication skills, including the ability to ensure complaint investigations, risk assessments, and regulatory justifications are clear, objective, contemporaneous, and audit‑defensible.
• Strong organizational and prioritization skills, with the ability to manage investigation workload, monitor action item status, and drive timely follow‑up and escalation across multiple stakeholders.
• In‑depth understanding of audit and inspection dynamics, with the ability to serve as a subject‑matter expert during internal and external audits related to complaint handling, post‑market surveillance, CAPA, and regulatory compliance.

• Continuous improvement mindset, with the ability to use investigation outcomes, trending data, and regulatory expectations to enhance post‑market surveillance and Quality Management System processes and tools.

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.

Experience:

• 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.

Education:

• Bachelor’s degree in a Health, Engineering or Science field required.

#LI-KA1

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 $90,000.00 - $120,000.00 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.