New · posted Oct 15
CooperVision · Medical Devices
Senior Manager, Global Quality Systems
- Trumbull, CT +1 more
- On-site
- Full-time
- Manager
Open until filled
The role
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.
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.
What you need
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.
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.
Required
- Bachelor’s degree in a relevant field such as Engineering, Life Sciences, Quality, or a related discipline.
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.
Preferrednice to have
- 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.
Preferrednice to have
- 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.
Preferrednice to have
- Professional ASQ certification (CQPA, CQA, CMQ/OE, etc.)
- Project Management Professional certification (PMP)
Pay
$140,499 – $180,000 a year
Employer providedPay transparency statement (CA, CO, CT, HI, IL, MD, MN, NJ, NY, VT, WA, or Remote)
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $140,499 - $180,000. 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.
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.
Where you'll work
Trumbull, CT +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Livingston, NJ
More jobs in Trumbull, CT +1 moreWorking conditions
- Standard office environment with regular use of computer systems and virtual collaboration tools.
Equal opportunity, accessibility and legal noticesCooperVision's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $140,499 | — | $180,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: CooperVision's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not CooperVision's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk21
- GMP and compliance16
- Collaboration and leadership12
- Data and digital systems4
- Regulatory submissions3
- Lab testing and methods1
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
CooperVision on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 5
- Locations
By discipline
- Quality9 90%
- Regulatory1 10%
By level
- Senior & Principal8 80%
- VP & Executive1 10%
- Manager1 10%
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