Director, Central Quality Audit
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (54.0%).
Occupation TypeFunctional managers and directors not elsewhere classified.
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£74,700
(£38.31 per hour)
Occupation rate applies
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Description
Job Description Summary
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. Stays informed of industry trends that may influence work.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities
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. Stays informed of industry trends that may influence work.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and 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.
- 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.
Desired Characteristics
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $142,400.00-$213,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
Additional Information
- 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%.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $142,400.00-$213,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: April 27, 2026
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: April 27, 2026