Director, Site Quality, El Paso Site

Job Description SummaryGE HealthCare is seeking a dynamic Director, Site Quality, to lead the Quality team at the El Paso site. This role is responsible for developing and executing the site’s Quality Management System, ensuring compliance with global regulatory requirements, and driving a culture of quality excellence. The Director, Site Quality, oversees all aspects of QMS performance, and compliance readiness while partnering closely with operations to ensure safe, effective, and compliant medical devices reach patients around the world.
The Director, Site Quality will be responsible for developing and maintaining systems, rules, and processes to ensure fulfillment of internal and external requirements. They ensure that projects and products are capable and will meet specified standards. The leader shall have an in-depth knowledge of best practices and how their own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market.

Job Description

Roles and Responsibilities

• Leads a team of quality professionals who support the overall site Quality Management System, including developing talent on the team.
• Champions the evolution of the quality culture which includes executing and driving quality objectives and metrics, reported on the standard site quality scorecard and monitored via the QMR to escalate actions appropriately and in a timely manner. 
• Implement and adhere to all applicable regulations at the site and ensure others do the same on a daily basis through education and training. 
• Represents GE Healthcare to external agencies. Ensure audit readiness is maintained and audit support is superbly executed. Serves as site’s management representative.
• Prioritize Quality actions and uses a risk-based approach – partner with other functions such as Manufacturing, Engineering, and Supplier Quality to determine ownership, priority, timing, and resolution. 

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 10 years of experience in Quality).
• This role requires significant experience in Quality & Healthcare Quality
• 8+ years of experience

Desired Characteristics

• Strong oral and written communication skills in both English and Spanish. Demonstrated ability to analyze and resolve problems. Ability to document, plan, and execute programs.
• Demonstrated understanding and expertise to effectively communicate within all levels of the organization around concepts of document change control, production & process controls; Corrective & Preventive Action (CAPA) & risk management.
• Knowledge level comparable to a Master's degree or professional certification in Quality, Regulatory Affairs, or Project Management (e.g., ASQ, PMP).
• Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.