Team Lead, Lead Quality Engineer, Global Service

About the role

This role manages a team of four Quality Assurance Technicians and oversees Quality Assurance activities supporting medical device history record review, final acceptance, and product release.

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.

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.
• Availability to start at 7:00 a.m. CST.

Qualifications / Requirements

• 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.