Director, Central Quality Audit
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $139,200 - $208,800 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Owns the configuration of the electronic Quality Management System module for audit records
- Executes User Assessment Testing (UAT), manages change management, and ensures system documentation is maintained
- Executes against GEHC's Central Quality & Regulatory Audit program
- Supports GEHC Health / Competent Authority audits including preparation, tracking of Lessons Learned, and driving follow-up activities
- Supports GEHC Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues
- Regularly advises management in Central Quality
Requirements
- Master’s Degree and a minimum of 5 years’ experience in medical device and/or pharmaceutical industry
- Bachelor's Degree and a minimum of 10 years’ experience in medical device and/or pharmaceutical industry
- High School Diploma and a minimum of 15 years' of progressive responsibility in medical device and/or pharmaceutical industry
- Direct experience configuring, managing, and qualifying an electronic Quality Management System for audit records
- Qualified Lead Auditor with active certification
- Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues
- Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP
- Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 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
electronic Quality Management SystemUser Assessment Testingchange managementmetrics trackingquality compliance issue resolutionPharmaceutical QMS requirementsMedical Device QMS requirementscGMPGDPGCP
Soft skills
advising managementdriving follow-up activitiesearly awareness promotionvisibility of issues
Certifications
Qualified Lead Auditor