Sr Associate Specialist Quality - Healthcare Quality

Job Description

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills. Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters. A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others. Required Qualifications This role requires basic experience in the Quality Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college. Knowledge of ISO 13485 and medical device regulations for eg 21 CFR and EU MDR Desired Characteristics Basic experience in ISO 13485 quality management standards and medical device regulations Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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. 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 Additional Information Relocation Assistance Provided: No