Job Summary

• Owns the configuration of the electronic Quality Management System module for audit records, executing User Assessment Testing (UAT), managing change management, and ensuring system documentation is maintained.
• Executes against GEHC's Central Quality & Regulatory Audit program, including scheduling, preparation, execution, reporting, and follow-up activities, while supporting Health / Competent Authority audits.
• GE HealthCare offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Matching Summary

Salary

Base: $142,400.00-$213,600.00 Annual; Bonus/Equity: Performance based incentive compensation; Benefits: Medical, dental, vision, paid time off, 401(k), life, disability, accident insurance, tuition reimbursement

Skills & Requirements

Key Requirements

• Master’s Degree and 5 years' experience OR Bachelor's Degree and 10 years' experience OR High School Diploma and 15 years' progressive responsibility in medical device and/or pharmaceutical industry
• Direct experience configuring, managing, and qualifying an electronic Quality Management System
• Qualified Lead Auditor with active certification
• Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues
• Experience with Pharmaceutical QMS and regulatory requirements (cGMP, GDP, GPvP, GCP, GLP)
• Experience with Medical Device QMS and regulatory requirements (FDA CFR 21 820, ISO 13485)

Work Rights