Senior Lead Specialist, Quality

Summary In this role you will develop and maintain systems rules and processes to ensure fulfillment of internal and external requirements You will ensure that projects and products are capable and will meet specified standards Preventive You will have In-depth understanding of key business drivers uses this understanding to accomplish own work You will ensure each project is developed released meeting customer expectations and regulatory requirements GE Healthcare is a leading global medical technology and digital solutions innovator Our mission is to improve lives in the moments that matter Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world Roles and Responsibilities 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 Supports continuous product and process improvement through detailed failure analysis for nonconformances and investigates develops and implements effective and compliant solutions for product or process corrections retrospective and remediation action plans and for corrective and preventive actions CAPA Program Developing in-depth knowledge of a discipline Uses prior experience and acquired expertise to execute functional policy strategy A job at this level is likely to be an individual contributor with proven interpersonal skills Communication with direct colleagues and the business about design and coordination services rendered Provides informal guidance to new team members Explains complex information to others in straightforward situations Impacts projects processes and procedures in own field The role operates with some autonomy but is focused on execution of activities provision of advice within an enabling discipline covered by standard functional practices and procedures Activities require professional judgment but may require more senior levels of guidance Utilizes technical expertise and judgement to solve problems Leverages technical skills and analytic thinking required to solve problems May use multiple internal sources outside of own team to arrive at decisions Required Qualifications This role requires advance experience in ISO 13485 and SDLC 62304 domain in a regulated industry such as FDA EUMDD MDR Demonstrated knowledge on cybersecurity and privacy regulations Knowledge level is comparable to a Bachelor s degree from an accredited university or college or a high school diploma with relevant experience Minimum Years of experience in the relevant industry - 5 to 10 Years or more Desired Characteristics Strong oral and written communication skills Demonstrated ability to analyze and resolve problems Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to ISO 13485 and FDA 21 CFR 820 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