Director, Central Quality Audit

GE HealthCare

Director overseeing compliance with quality and regulatory standards in medical device industry at GE HealthCare. Leading audit programs, improving processes, and advising management in regulatory best practices.

Posted 7/1/2026full-timeRemote • 🇺🇸 United StatesLead💰 $142,400 - $213,600 per yearWebsite

About the role

Key responsibilities & impact

Managing, ensuring and improving capabilities to comply with external standards and regulations
Interprets internal and external business challenges and recommends best practices to improve products, processes or services
Executes against GEHC's Central Quality & Regulatory Audit program
Scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits
Identification and communication of high-risk issues
Reporting compliance concerns and recommended improvements to business leadership
Ensures audit strategy is executed to current industry practices and regulatory expectations
Supports GEHC Health / Competent Authority audits
Preparation, back-room management, 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
Communicates difficult concepts and influences others' options on topics

Requirements

What you’ll need

Qualified Lead Auditor with active certification
Master’s Degree and a minimum of 5 years’ experience in the medical device industry; or Bachelor's Degree and a minimum of 10 years’ experience in the medical device industry; or will consider a High School Diploma and a minimum of 15 years' of progressive responsibility in the medical device industry
Minimum of 5 years’ Experience driving Global programs to resolve quality compliance issues (directly)
Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
Prior notified body or health authority experience a plus
ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt)
Design controls, design verification and validation activities
Production and process controls
Class III US FDA PMA Device requirements
CAPA, complaints and risk management
Understanding of product quality improvement using tools such as Six Sigma, DFR
Demonstrated ability to analyze and resolve problems
Exceptional conflict-resolution skills
Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner
Strong oral and written communication skills in English
Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.

Benefits

Comp & perks

medical
dental
vision
paid time off
a 401(k) plan with employee and company contribution opportunities
life
disability
accident insurance
tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Compliance ManagementAudit ExecutionDesign ControlsProcess ControlsSix Sigma MethodologyProblem Analysis and ResolutionMetrics TrackingRegulatory ReportingLessons Learned ManagementConflict Resolution

Soft Skills

Strong Communication SkillsProfessional InterfacingInfluencing SkillsIntegrityConflict-Resolution Skills

Certifications

Lead Auditor CertificationASQ CertificationLean Certification