CooperSurgical · 3 days ago
Principal IS Architect, Quality Systems
Trumbull, CT
Full-time
Hybrid
Lead/Staff
$132K/yr - $188K/yr
15+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to enhancing the healthcare experience for women and families. The Principal Architect will lead the design and optimization of Quality systems across global business units, ensuring compliance and supporting innovation while managing vendor strategies and program execution.
Health CareMedical DeviceWomen's
Responsibilities
Collaborate with Internal teams (e.g., Quality, IT, business units) to ensure alignment and address their needs
Define and execute the global Quality Systems architecture roadmap
Champion innovation through AI/ML, predictive analytics, and digital transformation
Align systems strategy with corporate objectives and regulatory frameworks
Chair global governance boards for lifecycle management of Quality Systems
Lead vendor selection, contract negotiation, and performance oversight
Manage multi-million dollar budgets and global resource allocation
Lead enterprise-wide rollouts across geographies, ensuring localization and compliance
Manage project tasks, monitor progress, and ensure adherence to project timelines and deliverables
Present program status, risk mitigation, and ROI to senior leadership and regulatory bodies
Serve as executive liaison between IT, RA/QA, and business units
Documentation of Business Requirements and Testing required for IT Change Control and Validation activities
Ensure systems meet ISO 13485, 21 CFR Part 820/11, EU MDR, and other global standards
Oversee validation, change control, and audit readiness
Develop and manage deployment plans, resource allocation, and timelines
Lead change management initiatives to drive adoption and minimize disruption
Oversee development of training programs and SOPs
Ensure documentation supports compliance and operational excellence
Lead root cause analysis and resolution of system issues
Manage escalations with vendors and service partners
Identify and implement enhancements to system performance and user experience
Qualification
Required
In depth knowledge and use of cloud-based/on premise/SaaS Electronic Quality Management System (eQMS) in the Medical Device or Pharmaceutical industry
Able to simultaneously work on large scale projects as well as handle day-to-day operational requests
Participate in multiple projects by completing and updating project documentation
Document process design changes by conducting business and systems process analysis and design at a complex level
Focusing on quality improvement and data management while ensuring data is reliable and valid
Document process improvements including re-engineering and/or integrating new systems and processes with existing ones
Communication with internal and external customers to ensure systems provided meet the long-term business strategies
Demonstrated ability to learn new systems and applications quickly
Ability to lead requirements gathering meetings and gain feedback and input from all participants, and report on the outcome of meetings
Provide project level analysis – producing required project analysis documentation (business requirements, scope matrix, use cases, sequence diagrams, future state proposals, UAT plan)
Collaborate closely with developers to implement the requirements, provide necessary guidance to testers during QA process
Excellent written and verbal communication skills in English
Software proficiency including: Ability to use standard Microsoft Office apps to document changes, create business presentations
Expert using data analytic tools – proficient in SQL, advanced excel (VLOOKUP, Pivot tables, Graphing functions)
Knowledge of Reporting tools (ex. Power BI) and hands-on experience using dashboards, reports, and data imports and exports for business use
Able to understand business processes and document these processes using Visio or other flow-chart tools
Strong project management, Successfully manage multiple tasks with competing priorities, at any given point, strong relationship building skills & communication skills
15+ years in regulated industry systems leadership (Medical Device or Pharma)
Proven success in global GxP software implementations and enterprise transformation
Preferred
Experience with MasterControl, Windchill, Veeva, or TrackWise preferred
BA (or equivalent) in Engineering, Computer Science or Business Administration preferred
PMP or equivalent certification a plus
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal, sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
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