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Senior Quality Engineer

Hcjy Fa Us2 Oraclecloud Com CX 1 · North Tonawanda, NY, United States; US-North Tonawanda, North Tonawanda, NY, US · On Site · Active · $90,000–$115,000 / year · Oracle Recruiting Cloud / Fusion HCM

Job facts

FieldValue
CompanyHcjy Fa Us2 Oraclecloud Com CX 1
TitleSenior Quality Engineer
Normalized title-
Department / teamEngineering
LocationNorth Tonawanda, NY, United States
Work modelOn Site
Employment typeFull Time
Salary$90,000–$115,000 / year
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-06-08 / 2026-06-09
Changed / last seen2026-06-19 / 2026-06-22

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Linked records

CompanyHcjy Fa Us2 Oraclecloud Com CX 1
Source063b269b-849a-4216-8d0d-8fc4f7efa6f5
ATS providerOracle Recruiting Cloud / Fusion HCM

Description

Description 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. Responsibilities 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 compliance with cGMP and data integrity standards. Support site training initiatives and quality culture development, including training on Change Control, validation, and risk-based quality systems; provide mentorship and technical guidance to cross-functional teams. Serve as site SME for Change Control, validation oversight, equipment quality systems, and risk management, influencing quality strategy and decision-making at all levels. Perform other duties as assigned. Travel: This position may require 10-20% domestic and/or international travel. Qualifications Knowledge, Skills and Abilities: Advanced expertise in risk management methodologies (e.g., FMEA, hazard analysis, risk ranking tools) and their application in regulated environments. Strong experience applying ICH Q9 risk management principles within a pharmaceutical or medical device QMS. Proven ability to lead risk-based decision making across multiple quality systems. Advanced knowledge of Change Control ownership and governance. Deep understanding of validation and equipment lifecycle risk management. Extensive experience in investigations, CAPA, and root cause analysis with risk prioritization. Experience supporting or leading regulatory inspections and audit responses. Strong understanding of FDA (21 CFR 210/211/820) and ISO standards (ISO 13485). Ability to influence cross-functional stakeholders using data-driven risk insights. Excellent analytical, communication, and leadership skills. Ability to operate as the senior QA engineering authority onsite. Work Environment: Production/Clean Room/Warehouse/Office 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 experience working in regulated manufacturing environment preferably within pharmaceutical or medical device related field. Significant experience leading risk-based quality systems, Change Control, and validation oversight. Demonstrated role as a senior or lead QA professional. Education: Bachelor’s degree in a Health, Engineering or Science field, or associate’s degree with 5+ years of relevant experience, or high school diploma with 10+ years of relevant experience required. Advanced degree preferred. #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 - $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.

Full job record

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Org IDfd5c005d-2102-408b-80a5-9404893f9b97
Source ID063b269b-849a-4216-8d0d-8fc4f7efa6f5
Board ID063b269b-849a-4216-8d0d-8fc4f7efa6f5
Provideroracle_hcm
Provider Job Key11553
TitleSenior Quality Engineer
Normalized Title—
Statusactive
Activeyes
Location TextNorth Tonawanda, NY, United States; US-North Tonawanda, North Tonawanda, NY, US
DepartmentEngineering
Team—
Employment Typefull_time
Workplace Typeon_site
Remote Policy—
CountryUnited States
RegionNY
CityNorth Tonawanda
Salary Rawbase pay for this role is between $90,000.00 - $115,000.00 annually
Salary Min90,000
Salary Max115,000
Salary CurrencyUSD
Salary Periodyear
Source URLhttps://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/11553
Apply URLhttps://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/11553
First Seen At2026-06-09 11:09:24Z
Last Seen At2026-06-22 14:45:53Z
Last Checked At2026-06-22 14:45:53Z
Last Changed At2026-06-19 10:59:02Z
Inactive At—
Source Posted At2026-06-08 13:19:12Z
Source Updated At—
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    "ExternalDescriptionStr": "<p class=\"elementtoproof\"><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\"><strong>About CooperSurgical</strong></span></span></p><p style=\"background-color: white; margin-bottom: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">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&nbsp;</span></span><a href=\"http://www.coopersurgical.com\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">www.coopersurgical.com</span></span></a><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">.&nbsp;</span></span></p><p style=\"margin: 0in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Work location:</strong> North Tonawanda, NY (on-site)</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Scope:&nbsp;</strong></span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Job Summary:</strong>&nbsp;</span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><span>&nbsp;</span></span></p>",
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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&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">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.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">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.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">For U.S. locations that require disclosure of compensation, the starting base pay&nbsp;for this role is between&nbsp;$90,000.00 - $115,000.00 annually. The&nbsp;actual base pay&nbsp;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.</span></span></p>",
    "InternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Advanced expertise in risk management methodologies (e.g., FMEA, hazard analysis, risk ranking tools) and their application in regulated environments.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong experience applying ICH Q9 risk management principles within a pharmaceutical or medical device QMS.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Proven ability to lead risk-based decision making across multiple quality systems.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Advanced knowledge of Change Control ownership and governance.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Deep understanding of validation and equipment lifecycle risk management.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Extensive experience in investigations, CAPA, and root cause analysis with risk prioritization.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience supporting or leading regulatory inspections and audit responses.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong understanding of FDA (21 CFR 210/211/820) and ISO standards (ISO 13485).&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ability to influence cross-functional stakeholders using data-driven risk insights.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Excellent analytical, communication, and leadership skills.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ability to operate as the senior QA engineering authority onsite.</span></span></li></ul><p>&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Occasionally lift to 35 pounds.</span></span></li></ul><p style=\"line-height: 106%;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">5+ years experience working in regulated manufacturing environment preferably within pharmaceutical or medical device related field.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Significant experience leading risk-based quality systems, Change Control, and validation oversight.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Demonstrated role as a senior or lead QA professional.</span></li></ul><p style=\"line-height: 115%; margin: 0in 0in 8pt 0.25in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Bachelor’s degree in a Health, Engineering or Science field, or associate’s&nbsp;degree&nbsp;with 5+ years of relevant&nbsp;experience,&nbsp;or high school diploma with&nbsp;10+ years of relevant experience required.</span></span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Advanced degree preferred.</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\">#LI-KA1</p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">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&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">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.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">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.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">For U.S. locations that require disclosure of compensation, the starting base pay&nbsp;for this role is between&nbsp;$90,000.00 - $115,000.00 annually. The&nbsp;actual base pay&nbsp;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.</span></span></p>",
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    "ExternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Review and approve complex quality documentation, ensuring accuracy, completeness, and compliance with cGMP and data integrity standards.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Support site training initiatives and quality culture development, including training on Change Control, validation, and risk-based quality systems; provide mentorship and technical guidance to cross-functional teams.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Serve as site SME for Change Control, validation oversight, equipment quality systems, and risk management, influencing quality strategy and decision-making at all levels.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Perform other duties as assigned.</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong>&nbsp;</span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">This position may require 10-20% domestic and/or international travel.&nbsp;</span></p>",
    "InternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">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.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Review and approve complex quality documentation, ensuring accuracy, completeness, and compliance with cGMP and data integrity standards.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Support site training initiatives and quality culture development, including training on Change Control, validation, and risk-based quality systems; provide mentorship and technical guidance to cross-functional teams.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Serve as site SME for Change Control, validation oversight, equipment quality systems, and risk management, influencing quality strategy and decision-making at all levels.</span></li><li style=\"margin-bottom: 0in; margin-top: 0in;\"><span style=\"font-family: Arial, sans-serif;\">Perform other duties as assigned.</span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong>&nbsp;</span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">This position may require 10-20% domestic and/or international travel.&nbsp;</span></p>",
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    "ShortDescriptionStr": "About CooperSurgical\n\nCooperSurgical 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. \n\nWork location: North Tonawanda, NY (on-site)",
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