Medical Device Quality Assurance Expert
20 hours ago
Our Culture
At GE HealthCare, we value innovation, collaboration, and excellence. We strive to create a workplace culture that fosters care, collaboration, and support. Our employees are empowered to take ownership and drive results with speed and efficiency.
Job Description
This position will serve as the primary Quality Assurance resource for the Cardiovascular Ultrasound Design and Development team. The successful candidate will be responsible for ensuring adherence to our Quality Management System throughout all phases of our Design and Development programs, from initiation to product launch.
Responsibilities
- Quality Assurance Excellence: Serve as the primary Quality Assurance resource within New Product Development (NPI) and Design Change projects.
- Compliance Management: Ensure compliance with the GE Healthcare Quality Management System under ISO 13485 and other applicable standards and regulations.
- Program Management: Collaborate efficiently with Program Management teams from program initiation to completion.
- Solution Development: Partner with GE Healthcare Subject Matter Experts to identify solutions that are both lean and compliant with standards and regulations.
- Conflict Resolution: Resolve compliance conflicts within projects.
Requirements
- Bachelor's degree in Engineering or a relevant discipline.
- Proven experience in the field of Quality Assurance.
- Strong problem-solving skills, with the ability to manage and resolve conflicts and propose solutions to both internal team members and external clients.
- Operational mindset with the ability to translate strategy into action, demonstrating a strong sense of urgency to drive outcomes with speed and efficiency.
- Proficient in computer-based platforms and tools.
- Strong oral and written English communication skills.
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