GE HealthCare Quality Systems Leader 

Ireland, Cork 

533204411

• 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.

• 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)

• 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

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.