Director, Quality & Regulatory – Digital Core Transformation
GE HealthCare
full-time
Posted on:
Location Type: Office
Location: Waukesha • Wisconsin • United States
Visit company websiteExplore more
Salary
💰 $142,400 - $213,600 per year
Job Level
About the role
- Leads the Quality and Regulatory (Q&R) workstream for the Next Generation 'Digital Core' transformation replacing key existing IT systems.
- Ensuring that all processes, data, and system capabilities enable compliant product realization and quality requirements.
- Partners with Q&R Process Owners (e.g., Design Controls, PPC/Product Hold, Supplier Quality, UDI) and other Functions/Program Leaders to help define requirements, validate solutions, and drive adoption while maintaining alignment to global Q&R expectations.
- Define the Validation strategy with the Global CSV team to ensure consistency and appropriate level of qualification required.
- Manage the holistic plans for Q&R involvement and resource requirements.
Requirements
- Bachelor’s degree and 8+ years of work experience – specifically in project / program management.
- Extensive experience in Quality and/or Regulatory roles within a regulated medical device and Drug environments.
- Strong working knowledge in multiple areas of the GE HealthCare Quality Systems and extensive use of these and/or related GE HealthCare IT Systems.
- Demonstrated leadership in cross-functional, enterprise-scale transformations (process, data, and/or business systems).
- Experience defining requirements and acceptance criteria and leading user testing/validation activities for enterprise systems impacting regulated processes.
Benefits
- medical
- dental
- vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life insurance
- disability insurance
- accident insurance
- tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementprogram managementquality assuranceregulatory compliancevalidation strategyuser testingacceptance criteriadata managementprocess improvementsystem qualification
Soft Skills
leadershipcollaborationcommunicationproblem-solvingcross-functional teamworkstrategic planningstakeholder engagementresource managementadaptabilityanalytical thinking