GE HealthCare Lead Quality Engineer 

Israel 

310213436

We are seeking an enthusiastic Lead Quality Engineer to join our Haifa 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. This role involves developing and maintaining systems, procedures, and processes to ensure compliance with internal and external requirements based on ISO 13485 standard.
Key Responsibilities

• Lead QMS and CAPA activities at the site, including, coordination and execution of quality training, employee qualification processes, coordination and management of the overall CAPA system, modification of procedures and practices and implementation of GE Healthcare procedures.
• Facilitation of internal/external audits and quality management reviews.
• Ensure regulatory compliance and optimize quality system procedures.
• Development and implementation of employee training
• Development and implementation of quality metrics to drive improvement and business results.
• Perform investigations, action plan activities, CAPA effectiveness check to ensure timely closure.
• Collect and compile appropriate data and metrics for CAPA board reviews.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Acts as a resource for colleagues with less experience. Lead local improvement projects and be part of global GE Healthcare projects/initiatives.
• Provide direction and guidance to peers to assist with their learning and effectiveness.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 3 years of experience in the medical device or pharmaceutical industry.
• Minimum of 3 years of experience with QMS and CAPA systems, including complaint handling.
• Proficiency in applying regulations (FDA, ISO 13485).
• Effective communication skills in English (both written and oral).

Desired Characteristics

• Stress Tolerance: Ability to accept constructive criticism and remain calm in high-stress situations.
• Team Orientation: Strong interpersonal skills and responsiveness to customer needs.
• Auditor Certification and experience in a multi-disciplinary company are advantageous.
• Ability to multi-task & handle tasks with competing priorities effectively.
• Ability to work independently in fast-paced environment with little supervision.
• Strong Problem-Solving skills.
• Quality-Focused, Attentive to Detail and Results-Oriented.
• Experience with Training and course development – advantage.
• Experience with cross functional project teamwork and collaboration with R&D, RA, QA, Product, Program, and Operations team members – advantage.

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.