Manager, CAPA, MR-AVS Waukesha

Job Description Summary

In this role, you will lead the CAPA Quality System for a large, multi-modality design center. You will drive timely, high-quality CAPA outcomes through strong project management, Lean methodologies, structured problem solving, and cross-functional collaboration.

As a key member of the Site Quality leadership team, you will partner with Engineering, Complaint Handling, and Regulatory Affairs, to apply the CAPA problem solving process to protect patient safety, strengthen quality systems, improve product quality, and ensure regulatory compliance.

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

Job Description

Roles and Responsibilities

• Ensures all areas of the Quality Management System (QMS) are analyzed and evaluated for input to the CAPA process, problems are escalated and documented appropriately, and regulatory requirements are met.
• Manages execution of the CAPA system employing project management, problem solving, and lean methodologies to ensure robust quality decisions and CAPA timeliness.
• Leads CAPA Review Boards, partnering with top leadership to proactively address risks.
• Owns site trending and data analysis for inputs to the CAPA process.
• Leads others to find creative solutions to address complex problems using a variety of statistical and analysis techniques.
• Ensures site audit readiness and hosts Quality System audits, representing GE HealthCare to external agencies.
• Coaches and develops others in their organization as an expert individual contributor.

Required Qualifications

• Bachelor's degree from an accredited university or college (or at least 6 years of relevant work experience in Medical Devices, or similar regulated industry)
• At least 5 years of relevant Quality, Design, or Manufacturing Engineering experience in a regulated industry, either Medical Devices or Pharmaceuticals preferred
• Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.

Desired Characteristics

• Established project management skills and Lean expertise. Ability to lead cross-functional teams to plan and execute projects on time.
• Demonstrated understanding of Medical Device QMS and regulatory requirements including but not limited to FDA Quality Management System Regulation (QMSR, 21 CFR Part 820), MDSAP, and ISO 13485.
• 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, for 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.
• Experience with emerging digital and AI-enabled tools, with the ability to experiment and apply them to improve outcomes in the CAPA system.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Additional Information

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.