Sr Lead Specialist, 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). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description 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. 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. Assess changes in regulations and global QMS , develop and implement QMS implementation plans. Maintain site QMS including procedures, Work instructions and templates for Manufacturing and Design scope Manage Internal Audit program including planning, execution and closure by identifying audit team and leading them Conduct Quality Management reviews and ensure the Quality Management system is effective and efficient Required Qualifications Role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Working Knowledge on ISO13485 standard and Medical device regulations Skilled in Program Management methodologies Efficient in communication Desired Characteristics Working experience in Medical Device industry Prior experience in managing Quality Management System including Quality manual, Procedures and Work instructions Prior Internal Audit experience as Auditor/lead Auditor/Audit coordinator Skilled In Influencing skills and conflict management methodologies