CooperSurgical Visa Sponsorship Jobs USA
CooperSurgical is a medical device and reproductive health company operating within the competitive Biotechnology & Pharmaceuticals sector. It has an established track record of sponsoring both H-1B visa and employment-based Green Cards, making it a credible option for international professionals targeting science, engineering, and clinical roles in the U.S.
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Scope: The Senior Manager, Global Quality Systems provides leadership and oversight for key elements of CooperSurgical's Global Quality Management System (QMS), including Management Review, Quality System Metrics and Reporting, Regulatory Intelligence, Quality System Impact Assessments, and Quality System integration activities associated with acquisitions and strategic business initiatives. Partners closely with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, IT, and other functional leaders to ensure QMS remains compliant, effective, scalable, and aligned with evolving regulatory requirements and business objectives. Serves as a key partner to the Director, Global Quality Systems, helping drive quality system performance, governance, inspection readiness, and continuous improvement across the global organization.
Responsibilities
Job Summary: The Senior Manager, Global Quality Systems is responsible for the leadership, oversight, and continuous improvement of key components of CooperSurgical's Global Quality Management System. This role ensures ongoing compliance with applicable global regulations and standards, including FDA QMSR, ISO 13485, MDSAP, EU MDR, and other relevant requirements. Leads activities related to Management Review, Quality System metrics and reporting, regulatory intelligence, standards management, quality system impact assessments, and merger and acquisition integration efforts. Through effective governance, analytics, and cross-functional collaboration, this role provides visibility into QMS health, identifies compliance risks and opportunities, and ensures regulatory and standards changes are effectively assessed and incorporated into the Quality Management System.
Essential Functions & Accountabilities:
- Support the governance, effectiveness, and continuous improvement of the global QMS.
- Drive harmonization, compliance, and operational excellence across global quality system processes.
- Partner with process owners and cross-functional stakeholders to identify and mitigate quality system risks while ensuring inspection readiness.
- Lead the global Management Review program, including planning, reporting, action tracking, and continuous improvement.
- Develop and maintain quality system KPIs, dashboards, and performance reporting to provide visibility into QMS effectiveness, compliance status, and emerging risks.
- Prepare executive-level reporting on QMS health, quality objectives, risks, and improvement opportunities.
- Monitor process effectiveness and drive improvements that enhance compliance, efficiency, and user experience.
- Monitor evolving global regulations, standards, guidance documents, and industry best practices impacting the Quality Management System.
- Lead quality system impact assessments and gap analyses to determine the effect of regulatory and standards changes on existing QMS processes.
- Develop and track implementation plans to ensure timely incorporation of regulatory and standards requirements into the QMS.
- Partner with Regulatory Affairs and Quality leadership to evaluate new or revised regulatory requirements.
- Lead Quality Systems due diligence, integration planning, and QMS harmonization activities associated with acquisitions and strategic business initiatives.
- Assess quality system maturity, identify compliance gaps, and implement integration plans that align acquired entities with CooperSurgical processes.
- Support implementation and optimization of electronic Quality Management Systems (eQMS) and related quality system enhancement initiatives.
- Support regulatory inspections, audits, and remediation activities as required.
- Lead, coach, and develop a team responsible for Quality Systems governance, reporting, compliance monitoring, and improvement initiatives.
- Establish performance expectations, prioritize resources, and foster a culture of quality, accountability, and continuous improvement.
Travel: This position may require 20% domestic or international travel.
QUALIFICATIONS
Knowledge, Skills and Abilities:
Required
- Strong working knowledge of MasterControl, Veeva, Trackwise, or similar eQMS platforms.
- Solid understanding of 21 CFR 820, ISO 13485, EU MDR, MDSAP.
- Demonstrated ability to manage and develop teams.
- Ability to balance operational priorities with compliance requirements.
- Strong organizational, analytical, and communication skills.
- Ability to collaborate across global, cross-functional groups.
Preferred
- Experience participating in or supporting large-scale enterprise software implementations, including data migration and data mapping activities.
- Advanced proficiency in Excel for data analysis and reporting.
- Professional certification such as Certified Quality Auditor (CQA) or similar.
Work Environment:
- Standard office environment with regular use of computer systems and virtual collaboration tools.
Experience:
Required
- 8+ years of experience in quality management systems, within a regulated med tech industry.
- 7+ years of people leadership and team development.
- Experience managing quality systems with ISO 13485 and FDA 21 CFR Part 820, MDSAP, and EU MDR requirements.
Preferred
- Exposure to other adjacent quality system compliance requirements such as 21 CFR Part 210/211.
- Prior involvement in supporting external and internal audits.
- Experience with electronic Quality Management Systems (eQMS) and/or implementation of eQMS, such as Veeva, Trackwise, MasterControl.
Education:
Required
- Bachelor’s degree in a relevant field such as Engineering, Life Sciences, Quality, or a related discipline.
Preferred
- Professional ASQ certification (CQPA, CQA, CMQ/OE, etc.)
- Project Management Professional certification (PMP)
JOB DESCRIPTION
Scope: The Senior Manager, Global Quality Systems provides leadership and oversight for key elements of CooperSurgical's Global Quality Management System (QMS), including Management Review, Quality System Metrics and Reporting, Regulatory Intelligence, Quality System Impact Assessments, and Quality System integration activities associated with acquisitions and strategic business initiatives. Partners closely with Quality, Regulatory Affairs, Operations, Manufacturing, R&D, Supply Chain, IT, and other functional leaders to ensure QMS remains compliant, effective, scalable, and aligned with evolving regulatory requirements and business objectives. Serves as a key partner to the Director, Global Quality Systems, helping drive quality system performance, governance, inspection readiness, and continuous improvement across the global organization.
Responsibilities
Job Summary: The Senior Manager, Global Quality Systems is responsible for the leadership, oversight, and continuous improvement of key components of CooperSurgical's Global Quality Management System. This role ensures ongoing compliance with applicable global regulations and standards, including FDA QMSR, ISO 13485, MDSAP, EU MDR, and other relevant requirements. Leads activities related to Management Review, Quality System metrics and reporting, regulatory intelligence, standards management, quality system impact assessments, and merger and acquisition integration efforts. Through effective governance, analytics, and cross-functional collaboration, this role provides visibility into QMS health, identifies compliance risks and opportunities, and ensures regulatory and standards changes are effectively assessed and incorporated into the Quality Management System.
Essential Functions & Accountabilities:
- Support the governance, effectiveness, and continuous improvement of the global QMS.
- Drive harmonization, compliance, and operational excellence across global quality system processes.
- Partner with process owners and cross-functional stakeholders to identify and mitigate quality system risks while ensuring inspection readiness.
- Lead the global Management Review program, including planning, reporting, action tracking, and continuous improvement.
- Develop and maintain quality system KPIs, dashboards, and performance reporting to provide visibility into QMS effectiveness, compliance status, and emerging risks.
- Prepare executive-level reporting on QMS health, quality objectives, risks, and improvement opportunities.
- Monitor process effectiveness and drive improvements that enhance compliance, efficiency, and user experience.
- Monitor evolving global regulations, standards, guidance documents, and industry best practices impacting the Quality Management System.
- Lead quality system impact assessments and gap analyses to determine the effect of regulatory and standards changes on existing QMS processes.
- Develop and track implementation plans to ensure timely incorporation of regulatory and standards requirements into the QMS.
- Partner with Regulatory Affairs and Quality leadership to evaluate new or revised regulatory requirements.
- Lead Quality Systems due diligence, integration planning, and QMS harmonization activities associated with acquisitions and strategic business initiatives.
- Assess quality system maturity, identify compliance gaps, and implement integration plans that align acquired entities with CooperSurgical processes.
- Support implementation and optimization of electronic Quality Management Systems (eQMS) and related quality system enhancement initiatives.
- Support regulatory inspections, audits, and remediation activities as required.
- Lead, coach, and develop a team responsible for Quality Systems governance, reporting, compliance monitoring, and improvement initiatives.
- Establish performance expectations, prioritize resources, and foster a culture of quality, accountability, and continuous improvement.
Travel: This position may require 20% domestic or international travel.
QUALIFICATIONS
Knowledge, Skills and Abilities:
Required
- Strong working knowledge of MasterControl, Veeva, Trackwise, or similar eQMS platforms.
- Solid understanding of 21 CFR 820, ISO 13485, EU MDR, MDSAP.
- Demonstrated ability to manage and develop teams.
- Ability to balance operational priorities with compliance requirements.
- Strong organizational, analytical, and communication skills.
- Ability to collaborate across global, cross-functional groups.
Preferred
- Experience participating in or supporting large-scale enterprise software implementations, including data migration and data mapping activities.
- Advanced proficiency in Excel for data analysis and reporting.
- Professional certification such as Certified Quality Auditor (CQA) or similar.
Work Environment:
- Standard office environment with regular use of computer systems and virtual collaboration tools.
Experience:
Required
- 8+ years of experience in quality management systems, within a regulated med tech industry.
- 7+ years of people leadership and team development.
- Experience managing quality systems with ISO 13485 and FDA 21 CFR Part 820, MDSAP, and EU MDR requirements.
Preferred
- Exposure to other adjacent quality system compliance requirements such as 21 CFR Part 210/211.
- Prior involvement in supporting external and internal audits.
- Experience with electronic Quality Management Systems (eQMS) and/or implementation of eQMS, such as Veeva, Trackwise, MasterControl.
Education:
Required
- Bachelor’s degree in a relevant field such as Engineering, Life Sciences, Quality, or a related discipline.
Preferred
- Professional ASQ certification (CQPA, CQA, CMQ/OE, etc.)
- Project Management Professional certification (PMP)
Job Roles at CooperSurgical
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Get Access To All JobsTips for Finding CooperSurgical Visa Sponsorship Jobs USA
Target roles aligned with CooperSurgical's core specialties
CooperSurgical's sponsorship activity centers on technical and scientific functions within reproductive health and medical devices. Focus your applications on roles in research, engineering, quality, and regulatory affairs where H-1B sponsorship is most commonly extended.
Understand both visa pathways CooperSurgical uses
CooperSurgical sponsors both H-1B visas and employment-based Green Cards. Knowing this matters, it signals the company invests in long-term talent retention, not just short-term work authorization. Ask about Green Card timelines during interviews.
Highlight specialty occupation qualifications clearly
H-1B eligibility at a biotech and medical device company like CooperSurgical requires demonstrating your role qualifies as a specialty occupation. Tailor your resume to show the direct connection between your degree and the specific technical demands of the position.
Research CooperSurgical's subsidiary and product divisions
CooperSurgical operates across multiple product lines and acquisitions. Sponsored roles may sit within specific business units, so research each division's hiring activity and apply broadly across the portfolio to maximize your chances of finding a sponsoring team.
Browse verified sponsorship history before applying
Confirming a company's real sponsorship history saves you from wasted applications. Migrate Mate surfaces verified sponsors so you can filter by actual sponsorship history, including CooperSurgical, and find open roles with confidence.
Prepare for a structured corporate hiring process
As a pharmaceutical and medical device company, CooperSurgical follows a rigorous hiring process with multiple interview rounds. Expect competency-based questions and technical assessments. Starting the process early gives you time to secure sponsorship approval before your current status expires.
Frequently Asked Questions
Does CooperSurgical sponsor H-1B visas?
Yes, CooperSurgical sponsors H-1B visas. The company operates in the Biotechnology & Pharmaceuticals sector and regularly hires international professionals in technical and scientific roles that qualify as specialty occupations under H-1B requirements. Sponsorship tends to be concentrated in functions like engineering, quality assurance, regulatory affairs, and research and development.
What types of visas does CooperSurgical sponsor?
CooperSurgical sponsors both H-1B nonimmigrant work visas and employment-based Green Cards, primarily in the EB-2 and EB-3 categories. The presence of Green Card sponsorship is a strong signal that the company supports long-term immigration pathways, not just temporary work authorization. This makes it a meaningful option for candidates seeking a path to permanent residency.
Which departments or roles at CooperSurgical are most likely to receive visa sponsorship?
Sponsorship at CooperSurgical is most common in technically specialized roles tied to its medical device and reproductive health product lines. This includes positions in research and development, quality engineering, regulatory affairs, clinical operations, and software or systems engineering. Roles requiring a specific degree in a scientific or technical field are the strongest candidates for H-1B qualification.
How do I know if a specific CooperSurgical job listing includes visa sponsorship?
Job listings don't always state sponsorship availability explicitly, which makes it difficult to know upfront. The most reliable approach is to cross-reference CooperSurgical's verified sponsorship history before applying. Migrate Mate lets you browse CooperSurgical's open roles alongside its real sponsorship track record, so you can apply with confidence rather than guessing from a job description.
How do I approach the application timeline when targeting CooperSurgical for H-1B sponsorship?
Timing is critical. The H-1B cap lottery opens in March for an October 1 start date, so you need an offer and a willing employer well before then. If you're on OPT, factor in your expiration date and apply to CooperSurgical early enough to give both parties time to prepare the petition. Cap-exempt situations, such as if CooperSurgical places you at a qualifying institution, may offer more flexibility.