We are seeking a Lead Quality Engineer for our Cardiovascular Ultrasound Design and Development team, specializing in ISO 13485 Medical Device Quality Management. As the primary Quality Assurance resource, you will ensure adherence to our Quality Management System throughout all phases of our Design and Development programs, from initiation to product launch.

Essential Responsibilities:

Serve as the Quality Assurance lead within New Product Development (NPI) and Design Change projects.
Ensure compliance with the GE Healthcare Quality Management System under ISO 13485 and other applicable standards and regulations. Review and approve QMS documentation and deliverables throughout all phases of NPI projects.
Collaborate efficiently with Program Management teams from program initiation to completion. Manage the planning of Quality Assurance deliverables within the programs and ensure progress to plan.
Partner with GE Healthcare Subject Matter Experts to identify solutions that are both lean and compliant with standards and regulations.
Resolve compliance conflicts within projects.

Qualifications / 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.

Desired Characteristics:

Prior experience in the healthcare industry.
Experience with ISO 13485 Medical Device Quality Management standards and medical device regulations, such as 21 CFR 820.
Demonstrated team orientation and ability to motivate and work well with diverse, cross-functional teams in matrixed settings.
Strong presentation skills.

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