Quality Systems Director

Title: Quality Systems Director

About Us: GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.
GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer.

Role Summary/Purpose: The Quality Systems Director is responsible for driving the vision, strategy, management and evolution of the Quality Management System (QMS).

Primary responsibilities include:

·Driving Quality Objectives at all levels in the organization in order to form a sustainable quality culture; based on compliance to regulations, patient safety, and continuous improvement of quality processes to benefit the end customer.

·Partnering with the business leadership team to drive wing-to-wing product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle. Run the Executive Management Review of Quality data and objectives.

·Acting as the interface between the business (P&L) and the Core QA/RA function, implementing Corporate GEHC programs in an appropriate compliant manner within the P&L.

·Driving training, , and adoption of the QMS documentation, framework and tools.

·Direct management responsibility for Quality Analytics, Training, Document Management and Computer Systems Validation staff.

·Providing effective guidance and oversight for quality processes, as well as owning key quality decisions for the total product life cycle.

·Ensuring compliance to existing and applicable global Quality Systems Requirements.

·Translating new industry trends and requirements into appropriate practices for the business.

·Managing internal and external audits across the business sites to ensure compliance as required by the business and regulatory agencies.

·Staffing and managing a globally disperse team of professionals with the required skills. and experience to effectively execute their job responsibilities.

Qualifications/Requirements:

1. Bachelor’s degree in Engineering or Scientific discipline or High School diploma/GED and a minimum of 10 years Quality Management experience in the medical device or pharmaceutical industry
2. Minimum 7 years working in a Quality Management role in a regulated industry and experience interfacing with the FDA
3. Minimum of 5 years supervisory experience (i.e. managing professional direct reports), including hiring, training, coaching and performance management activities
4. Strong knowledge of quality systems, including but not limited to ISO, GxP, FDA
5. Willingness to travel globally 20% of the time
6. Ability to communicate in English (oral and written)
7. You must be willing to submit to a background investigation, including for example, verification of past employment, criminal history and educational background.
8. You must be willing to take a drug test
9. You must be legally authorized to work in the United States
10. You must be willing to work out of an office located in Salt Lake City, Utah