Job Description Summary

Responsible for QA activities in support of medical device history record review, final acceptance and final product release. Ensures that products are capable and meet specified standards. Develops and maintain systems, rules and processes to ensure fulfillment of internal and external requirements. Understands key business drivers; uses this understanding to work with own team, integrates with other teams, and contributes to the site and business objectives.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Essential Responsibilities

• Provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members as applicable.
• Leads, acknowledges, develops, communicates & implements a strategy to ensure compliance.
• Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
• Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, corrective, and preventive actions (CAPA).
• Utilizes risk management tools in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.
• Drives implementation of lean processes and standard work.
• Applies technical expertise and judgment to solve problems, drawing on cross-functional resources as needed.
• Clearly conveys complex information to peers and leaders.
• Performs a broad variety of tasks in support of product and process design.

Qualifications / Requirements

• 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)
• Minimum of 4 years of experience working in a regulated industry.
• 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

• Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Strong oral and written communication skills.
• Experience leading and implementing change.
• Aptitude with digital workflows and IT systems.
• Demonstrated collaboration, negotiation, conflict resolution and leadership skills.
• Internal and external audit experience.
• Ability to effectively prioritize and execute projects to plan.
• Exceptional analytical, problem solving & root-cause analysis skills.
• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

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.

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

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.