Job Description Summary

As a CAPA Leader, you will lead the effective closure of all CAPA/Deviation/Change Control records within specific sites/ departments across the PDx network. In this role, you will drive timely, high-quality QMS record outcomes through strong project management, Lean methodologies, structured problem solving, and cross-functional collaboration.

As a key member of the Quality organisation, you will partner with stakeholders within Quality as well as Supply Chain, Operations, Engineering and Regulatory Affairs, to apply problem solving tools to protect patient safety, strengthen quality systems, improve product quality, and ensure regulatory compliance.

You will also represent GE HealthCare during internal and external audits and may interface with regulatory authorities.

Job Description

Responsibilities

• Ensuring all areas of the QMS are analyzed and evaluated for input to the QMS record, problems are escalated and documented appropriately, and regulatory requirements are met.
• Managing execution of the QMS records, employing project management, problem solving, and lean methodologies to ensure robust quality decisions and timeliness.
• Leading CAPA Review Boards, partnering with site leadership to proactively address risks.
• Owning site trending and data analysis for inputs to the CAPA/Deviation/Change Control process.
• Leading others to find creative solutions to address complex problems using a variety of statistical and analysis techniques.
• Ensuring site audit readiness and supports Quality System audits, representing GE HealthCare to external agencies.
• Coaching and develops others in their organization as an individual contributor.

 

Required Qualifications

• Bachelor's degree from an accredited university or college.

• Strong relevant Quality, Manufacturing or Engineering experience in a regulated industry, either Medical Devices or Pharmaceuticals.

 

Desired Characteristics

• Experienced user of the TWD system and the QA procedures governing Quality Events,
• Established project management skills and Lean expertise. Ability to lead cross-functional teams to plan and execute projects on time.
• Demonstrated understanding of a GMP QMS and regulatory requirements

• Exceptional analytical, problem solving & root-cause analysis skills

• Ability to effectively manage execution of tasks with competing priorities.

• Excellent communication skills – presentation, verbal and written to all organizational levels.
• Demonstrated collaboration and conflict resolution skills.
• Experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.

• Experience leading and implementing change.
• Strong interpersonal and leadership skills.

 

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