Job Description Summary

We are seeking an enthusiastic Lead Quality Engineer to join our Noblesville Ultrasound QA team, focusing on CAPA and QMS activities. The Lead Quality Engineer will provide guidance and support in accordance with CAPA and QMS documented procedures and practices in the areas of Ultrasound New Product Introduction, Design Transfer, Manufacturing/Remanufacturing/Refurbishment, Distribution, and Service. This role involves developing and maintaining systems, procedures, and processes to ensure compliance with internal and external requirements based on FDA CFR 21 820 and ISO 13485 standards.

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

Key Responsibilities

• Lead QMS and CAPA activities at the site and manage the overall CAPA system; This includes compliant execution of investigations, action plan activities, and CAPA effectiveness checks to ensure timely closure.
• Facilitate both internal/external audits and quality management reviews.
• Ensure regulatory compliance and optimize quality system procedures.
• Develop and manages key quality metrics and maintains associated trending.
• Identifies and drives initiatives to improve QMS processes and product quality.
• Leads process effectiveness through the development and monitoring of process and equipment verification and validation plans.
• Utilizes risk management tools and aids for use by the organization in accordance with documented procedures.
• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager. 

Required Qualifications

• Bachelor's Degree with a minimum of 5 years of experience in the medical device/pharmaceutical industry or a minimum of 10 years' work experience in medical device / pharmaceutical industry.
• Minimum of 3 years of experience with QMS and CAPA systems
• Demonstrated knowledge of structured problem solving
• Proficiency in applying regulations (FDA, ISO 13485).
• Effective communication skills in English (both written and oral).
• 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.

Preferred Characteristics 

• Demonstrated ability to develop & lead process implementation.
• Experience conducting internal and external audits.
• Auditor Certification is a plus.
• Problem Solving and/or Lean Certification is a plus.
• Exceptional conflict-resolution skills
• Team Orientation: Strong interpersonal skills and responsiveness to customer needs.
• Ability to multi-task & handle tasks with competing priorities effectively.
• Ability to work independently in fast-paced environment with little supervision.
• Experience with cross functional project teamwork and collaboration.
• Demonstrated knowledge of Quality Management System and tools.

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.