Quality Assurance Manager for Medical Devices
1 week ago
Estimated Salary: $120,000 - $150,000 per year
About UsGE Healthcare is a leading medical technology and digital solutions innovator committed to improving lives in the moments that matter. We strive to create a work environment that fosters care, collaboration, and support.
Job DescriptionWe are seeking an experienced Quality Assurance Manager to join our team at GE Healthcare. As a key member of our quality assurance team, you will be responsible for ensuring compliance with internal and external requirements based on FDA CFR 21 820 and ISO 13485 standards.
Main Responsibilities:- Lead QMS and CAPA activities: Manage the overall CAPA system, including compliant execution of investigations, action plan activities, and CAPA effectiveness checks.
- Ensure Regulatory Compliance: Optimize quality system procedures and ensure regulatory compliance with FDA and ISO standards.
- Develop and Maintain Key Quality Metrics: Create and maintain key quality metrics and trending reports.
- Improve QMS Processes and Product Quality: Identify initiatives to improve QMS processes and product quality.
To be successful in this role, you should have:
- Bachelor's Degree in a relevant field (e.g., engineering, life sciences)
- A minimum of 5 years of experience in the medical device/pharmaceutical industry or equivalent experience
- Minimum of 3 years of experience with QMS and CAPA systems
- Demonstrated knowledge of structured problem-solving and regulations (FDA, ISO 13485)
- Effective communication skills in English (both written and oral)
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
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