Principal IS Architect, Quality Systems

Principal IS Architect, Quality Systems

Company: Cooper Surgical

Cooper Surgical 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 Cooper Companies, we are 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

The Principal Architect leads the design, deployment, and optimization of Quality System, specifically eQMS, platforms across global business units. The Principal Architect partners with executive stakeholders, regulatory teams, and IT leadership to ensure systems meet compliance standards, support innovation, and enable scalable growth. The role includes ownership of vendor strategy, governance, and global program execution. The Principal Architect provides strategic leadership and oversight for the global architecture, implementation, and continuous improvement of Quality systems, with a primary focus on Electronic Quality Management Systems (eQMS).

This role drives enterprise-wide transformation initiatives, ensuring alignment with regulatory requirements, operational excellence, and long‑term business strategy across Cooper Companies.

• Strategic Leadership
  • 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.
• Governance & Oversight
  • Chair global governance boards for lifecycle management of Quality Systems.
  • Lead vendor selection, contract negotiation, and performance oversight.
• Global Program Management
  • 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.
• Executive Engagement
  • Present program status, risk mitigation, and ROI to senior leadership and regulatory bodies.
  • Serve as executive liaison between IT, RA/QA, and business units.
• Compliance & Validation
  • Document 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.
• Deployment & Change Management
  • Develop and manage deployment plans, resource allocation, and timelines.
  • Lead change‑management initiatives to drive adoption and minimize disruption.
• Training & Documentation
  • Oversee development of training programs and SOPs.
  • Ensure documentation supports compliance and operational excellence.
• Incident & Risk Management
  • Lead root‑cause analysis and resolution of system issues.
  • Manage escalations with vendors and service partners.
• Continuous Improvement
  • Identify and implement enhancements to system performance and user experience.

Travel: Travel up to 25% may be 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.
  • Focus on quality improvement and data management while ensuring data is reliable and valid.
  • Document process…