Senior Quality Management Specialist

4 days ago


Noblesville, United States GE Healthcare Full time

We are seeking an enthusiastic professional to lead our Noblesville Ultrasound QA team. The successful candidate will focus on CAPA and QMS activities, providing guidance and support in accordance with documented procedures and practices.

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Key Responsibilities:

  • Lead QMS and CAPA activities at the site, ensuring compliant execution of investigations, action plan activities, and CAPA effectiveness checks.
  • Facilitate internal/external audits and quality management reviews.
  • Ensure regulatory compliance and optimize quality system procedures.
  • Develop and maintain key quality metrics and trending.
  • Identify and drive initiatives to improve QMS processes and product quality.
  • Leads process effectiveness through the development and monitoring of process and equipment verification and validation plans.

Requirements:

  • 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).
  • Licence to work in the U.S. required.

Estimated Salary: $120,000 - $150,000 per year

At GE HealthCare, we offer a great work environment, professional development, challenging careers, and competitive compensation. Our mission is to improve lives in the moments that matter.



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