Quality Lead Specialist

Job Description

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 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. 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. Possesses knowledge on QMS parameters with respect to ISO 13485 standards, including but not limited to, prior experience in handling Non-conformances, CAPA, Concessions and Deviations. In-depth and hands-on knowledge on process risk assessment and risk management with respect to ISO 14971 will be a key responsibility. Understands the process principles and drives the establishing, monitoring, and maintenance of all key performance indicators for product and process quality, with the support of cross functional teams for ongoing projects and new projects Demonstrate knowledge on Medical devices Refurbishment, Repairs and Harvesting. Required Qualifications For roles outside of the USA- This 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). For roles in USA - Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Knowledge of standard and Regulations like ISO 13485, ISO 14971. Experienced with both Internal and External Audits in both Auditor and Auditee roles. Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.