Quality Systems Leader

3 weeks ago

Cork, Cork, Ireland GE HealthCare Full time
Job Description Summary

We are seeking a Quality Systems Leader to oversee and continuously improve our Quality Management System (QMS). This strategic role ensures compliance with regulatory and internal standards while leading key quality processes such as Complaints Management, Quality Management Review, and Annual Product Review. The ideal candidate brings strong leadership, deep knowledge of quality systems, and a passion for driving operational excellence in a dynamic, patient-focused environment.

GE HealthCare Ireland Limited, located in Carrigtohill, Co. Cork, is a global leader in the manufacture and distribution of X-ray and MRI Contrast Media. As part of our Pharmaceutical Diagnostics (PDx) business, we are committed to delivering the right dose to the right patient at the right time. Our modern, agile site supports patients worldwide with high standards of safety, quality, and compliance, contributing to life-changing diagnostic procedures every day.

Responsibilities

Job Description
  • Lead and maintain core quality systems including CAPA, Change Control, Document Management, Training, Audit Management, and Risk Management.
  • Oversee the complaints handling process, ensuring timely investigation, root cause analysis, and implementation of effective corrective and preventive actions.
  • Lead the preparation and execution of periodic QMRs, ensuring comprehensive analysis of quality system performance.
  • Manage the APR process to ensure timely and accurate review of product quality data and implementation of improvements.
  • Ensure the QMS meets all relevant regulatory requirements and support audits and inspections.
  • Identify and implement improvements to quality systems to enhance efficiency and compliance.
  • Lead and develop a team of quality professionals, fostering a culture of accountability and learning.
  • Develop and report on key quality metrics and communicate performance to senior leadership.
  • Oversee the quality training program to ensure employees are trained and competent.
  • Lead risk assessments and mitigation strategies related to quality systems and compliance.

Qualifications And Requirements
  • Bachelor's degree in a scientific, engineering, or related discipline (Master's preferred) or equivalent.
  • Strong experience in Quality Assurance or Quality Systems in a regulated industry.
  • Solid experience in people leadership, including team development and coaching.
  • Strong knowledge of global regulatory requirements and standards
  • Proven leadership experience with cross-functional teams.
  • Excellent communication, analytical, and problem-solving skills.
  • Experience with electronic QMS platforms (e.g., Veeva, TrackWise, MasterControl)

Desired Skills
  • Lean Six Sigma or similar continuous improvement certification.
  • Experience in leading regulatory inspections.
  • Ability to influence and drive change in a matrixed organization.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

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.

Additional Information

Relocation Assistance Provided: No

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