Apply on Employer Site

GE HealthCare · 2 days ago

Director, Central Quality Audit

United States

Full-time

Remote

Lead/Staff, Director/Executive

$142K/yr - $214K/yr

5+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. The Director of Central Quality Audit is responsible for managing and improving capabilities to comply with external standards and regulations, executing audit programs, and influencing quality and regulatory practices within the organization.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

U.S. Citizen Only

Responsibilities

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. This includes 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; and ensuring audit strategy is executed to current industry practices and regulatory expectations

Supports GEHC Health / Competent Authority audits. This includes 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

Requires specialized depth and/or breadth of expertise within a quality or regulatory discipline and ability to influence the development of strategy within own area, including participation in policy formulation

Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view

Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GEHC policy objectives

Uses high level of judgment to make decisions and handle complex tasks or problems. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision

Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results

Qualification

Electronic Quality Management SystemQualified Lead AuditorPharmaceutical QMS requirementsMedical Device QMS requirementsVeeva experienceTrackWise Digital experienceIRCA CertificationASQ CertificationLean CertificationSix SigmaConflict-resolution skillsOral communication skillsWritten communication skillsIntegrity

Required

Master's Degree and a minimum of 5 years' experience in medical device and/or pharmaceutical industry; or Bachelor's Degree and a minimum of 10 years' experience in medical device and/or pharmaceutical industry; or will consider a 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 (directly)

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

Preferred

Prior Veeva and TrackWise Digital experience a plus

Prior health authority experience a plus

IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt)

Extensive experience in the Medical Device and Pharmaceutical industry

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

Demonstrated ability to lead programs / projects. Ability to prioritize and drive multiple programs

Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions

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

Ability to travel globally up to 40%

Benefits

Medical

Dental

Vision

Paid time off

A 401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

Glassdoor4.2

GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees