Lead Quality Specialist

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensure that projects and products meet specified standards, leveraging an in‑depth understanding of key business drivers and how team work integrates with other teams to contribute to the business. Roles and Responsibilities Responsible for the Quality Management System and Compliance activities for the site Creates a Quality culture by driving compliance activities and Quality metrics Ensures quality and regulatory compliance while driving process effectiveness and efficiency Utilizes proven interpersonal skills to communicate with direct colleagues and the business Provides informal guidance to team members Concise explains complex information to others Operates with some autonomy, activities require professional judgment Utilizes professional experience, technical skills, and analytical thinking to provide compliance guidance to colleagues and assist with problem resolution May use multiple internal sources outside of own team to arrive at decisions Applies technical writing skill to maintain Quality procedures Represents GE HealthCare to external agencies Required Qualifications Bachelor’s Degree or a minimum of 4 years of relevant experience in Quality Management or a related field Hands‑on experience managing a Quality Management System (QMS), including internal audits, document control, and procedural updates Experience working in a regulated manufacturing environment (ISO standards), ideally within medical devices or related industries Experience working in a clean room and/or semiconductor environment Experience supporting or working with complex product lines (e.g., digital X-ray detectors or similar technologies) Demonstrated ability to work effectively in a smaller, fast‑paced team environment where individuals take on multiple responsibilities Strong collaboration skills with the ability to partner cross‑functionally and drive alignment across teams Effective written and verbal communication skills, including the ability to explain complex concepts clearly Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, etc.) Ability to manage multiple priorities and operate with strong self‑direction and accountability Desired Characteristics 3+ years of experience in a regulated industry Familiarity with ISO 13485 and medical device Quality Management System requirements Experience with key quality processes such as CAPA, internal/external audits, and root cause analysis Exposure to product lifecycle activities, including design changes, validation, and process control methodologies Experience interfacing with regulatory bodies or supporting inspections Strong analytical and problem‑solving skills with the ability to identify and resolve complex issues Demonstrated ability to contribute to or lead process improvements or change initiatives Benefits Competitive benefits package including medical, dental, vision, paid time off, 401(k), life, disability, accident insurance, and tuition reimbursement. Equal Opportunity Employer GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. #J-18808-Ljbffr HC1316 GE Precision Healthcare LLC