Essential Responsibilities

• Provide guidance to team members by facilitating issue resolution, resource planning, coaching, mentoring, and career development.

• Develop, communicate, and execute strategies that ensure regulatory and quality compliance.

• Lead the creation, implementation, and ongoing optimization of effective and efficient site processes.

• Represent GE HealthCare during interactions with external agencies and promote a strong quality culture through quality objectives, metrics, reporting, and operating mechanisms.

• Support continuous product and process improvement through detailed analysis of nonconformances, and lead investigations and implementation of corrective and preventive actions (CAPA).

• Apply risk management tools—including PFMEA, Fault Tree Analysis, and Failure Mode Analysis—in alignment with documented procedures.

• Drive adoption of lean processes and standard work.

• Use technical expertise and sound judgment to solve complex problems, leveraging cross-functional partners as needed.

• Communicate complex information clearly and effectively with peers and leadership.

• Perform diverse tasks supporting product and process design activities.

Qualifications / Requirements

• Bachelor’s degree from an accredited institution, or a minimum of 6 years of relevant experience in the medical device or similarly regulated industry.

• At least 5 years of experience in a regulated environment.

• People management or project leadership experience

• Requires availability to start at 7:00 a.m. CST.

Desired Characteristics

• Strong understanding of Medical Device Quality Management System requirements and regulations, including FDA 21 CFR Part 820 and ISO 13485.

• Excellent verbal and written communication skills.

• Demonstrated ability to lead and implement change.

• Proficiency with digital workflows and IT systems.

• Strong collaboration, negotiation, conflict‑resolution, and leadership capability.

• Experience conducting internal and external audits.

• Ability to prioritize and manage projects effectively.

• Exceptional analytical, problem-solving, and root‑cause analysis skills.

• Strong technical aptitude, including the ability to interpret technical documentation and execute procedures; global regulatory experience and direct interaction with regulators are a plus.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

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.