CAPA Leader

GE HealthCare

4d

About The Position

The CAPA Leader is responsible for driving effective and timely closure of CAPA, Deviation, and Change Control records for assigned sites or departments across the PDx network. The role uses project management, Lean methodologies, structured problem solving, and cross-functional collaboration to deliver high-quality QMS outcomes that protect patient safety, strengthen quality systems, improve product quality, and maintain regulatory compliance.

As a member of the Quality organization, the CAPA Leader partners with Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs stakeholders. The role leads CAPA Review Boards, owns site trending and data analysis, supports audit readiness, and represents GE HealthCare in internal and external audits, with possible interaction with regulatory authorities. As an individual contributor, the role also coaches and develops others.

Requirements

• Bachelor's degree from an accredited university or college.
• Significant Quality, Manufacturing, or Engineering experience in a regulated industry, either Medical Devices or Pharmaceuticals.
• Demonstrated understanding of a GMP QMS and regulatory requirements.
• Exceptional analytical, problem-solving, and root-cause analysis skills.
• Ability to manage task execution effectively amid competing priorities.
• Excellent presentation, verbal, and written communication skills across organizational levels.
• Demonstrated collaboration and conflict-resolution skills; experience in cross-functional environments and ability to influence and build consensus among multiple functions.
• Strong interpersonal and leadership skills.

Nice To Haves

• Experienced user of the TWD system and the QA procedures governing Quality Events.
• Established project management skills and Lean expertise, including ability to lead cross-functional teams to plan and execute projects on time.
• Experience leading and implementing change.

Responsibilities

• Analyze and evaluate QMS areas for input to QMS records; ensure problems are escalated and documented appropriately and regulatory requirements are met.
• Manage execution of QMS records using project management, problem-solving, and Lean methodologies to support robust quality decisions and timely completion.
• Lead CAPA Review Boards and partner with site leadership to proactively address risks.
• Own site trending and data analysis for CAPA, Deviation, and Change Control process inputs.
• Lead others in finding creative solutions to complex problems using statistical and analytical techniques.
• Ensure site audit readiness and support Quality System audits, representing GE HealthCare to external agencies.
• Coach and develop others as an individual contributor.
• Interface with regulatory authorities as needed.

What This Job Offers

• Job Type: Full-time