Senior Supervisor- Quality Engineering

About CooperSurgical

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

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 Partsand 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 postmarket 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:

• Bachelors degree in a Health Engineering or Science field required.

#LI-KA1

Our Benefits:

As an employee of CooperSurgical youll 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 atto 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 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 payfor this role is between$90000.00 - $120000.00 annually. Theactual base payincludes 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 riskbased product complaint investigations for combination drugdevice 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 crossfunctional meetings and decisionmaking forums to drive complaint resolution postmarket 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 followup 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 followup actions are completed in compliance with applicable regulatory requirements and internal procedures.
• Ensures the maintenance of complete accurate and traceable complaint and postmarket surveillance records within designated tracking systems and databases; monitors investigation progress and action item status and drives timely escalation when required.
• Ensures postmarket 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 postmarket surveillance metrics trending analyses and risk signals to leadership to support oversight decisionmaking and continuous improvement initiatives.
• Serves as a subjectmatter expert during internal and external audits and inspections related to complaint handling postmarket surveillance complaint CAPA escalation and regulatory compliance for combination products.
• Drives continuous improvement of postmarket 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 riskbased product complaint investigations including application of structured root cause analysis methodologies and evaluation of investigation quality for combination drugdevice products.
• Strong risk assessment and decisionmaking 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 crossfunctional 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 problemsolving capabilities with the ability to evaluate trends identify emerging postmarket risk signals and recommend proactive quality and system improvements.
• Demonstrated proficiency in maintaining and overseeing controlled complaint and postmarket 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 auditdefensible.
• Strong organizational and prioritization skills with the ability to manage investigation workload monitor action item status and drive timely followup and escalation across multiple stakeholders.
• Indepth understanding of audit and inspection dynamics with the ability to serve as a subjectmatter expert during internal and external audits related to complaint handling postmarket surveillance CAPA and regulatory compliance.

• Continuous improvement mindset with the ability to use investigation outcomes trending data and regulatory expectations to enhance postmarket 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 postmarket 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:

• Bachelors degree in a Health Engineering or Science field required.

#LI-KA1

Our Benefits:

As an employee of CooperSurgical youll 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 atto 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 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 payfor this role is between$90000.00 - $120000.00 annually. Theactual base payincludes 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.