Service Compliance Specialist

Business Unit: GE HealthcareFunction: ServicesResponsibilities: Responsible for supporing the compliance and quality program for Service. Provides direct maintenance of Service Records to include auditing. Represents Service Organization on Data and Document Control Quality team. Responsible for review, posting and routing for approvals of Service procedures using eLibrary system. Assists with assignment of SOP training within MyLearning. Processes registration and communication with State Regulatory Agencies. Participates on internal quality audit team. Represents Service organization as alternate attendee on Product Performance Core Team, CAPA Review Board and Quality Council. Works with Directors of Service to ensure regulatory compliance and quality. Occasional travel required performing field-based audits.Overall management of State Regulatory Agency Registrations. Includes renewal-processing, changes to existing registrations, and overall file maintenance.Internal communications regarding regulatory and quality issues.Review and auditing of Service Installation Records for compliance with FDA and State requirements. Tracks individual and region-level performance to paperwork submissions. Works with DOS and FE's to ensure compliance. Timely filing and maintenance of Service History files.Represents the Service Organization on the Data and Document Control Quality team. Handles review, posting and routing for approvals, all Service procedures using the eLibrary system. Assists with the assignment of SOP training within MyLearning. Periodic review and audit of Field Service Engineer (FSE) compliance. Will require occasional travel to FSE work locations to perform audits.Helps manage the review, documentation and filing of PM paperwork. Alternate member to participate on the Product Performance Core Team (PPCT), CAPA Review Board (CAB) and Quality Council. ~HJ~~NW~
REQUIREMENTS
Qualifications: *Associates or bachelor's degree or equivalent.*Excellent Organizational skills.*Computer skills: Excel and PowerPoint*Knowledge of quality systems and FDA requirements.Desired: Ability to analyze complex and judgmental regulatory issues.*Very good interpersonal, verbal and written skills. ability to handle multiple tasks.*Well-developed problem-solving skills and the ability to come up with various creative approaches to attack issues. Bachelor's degree. *Clarify database knowledge*Service experience and background preferred.General: GE Healthcare provides medical technologies that will help shape a new age of patient care. The business is dedicated to detecting disease earlier and tailoring treatment for individual patients. GE's Interventional, Cardiology and Surgery (ICS) business is a $1 billion global P&L with operations around the world, including: United States, Germany, China, Hungary, India, and France. The ICS business strives to meet customer needs by developing technologies that provide patients, physicians and payors with less invasive surgical options. ICS products are sold to the Cardiology, Interventional Radiology and Surgery markets. In the interventional space, we offer a fully integrated cath lab solution, complete with flat panel digital imaging, diagnostic monitoring systems, data management systems and a comprehensive IT platform to make it all work together. In the surgical space, our products range from mobile fluoroscopic imaging systems (c-arm) used for a wide variety of surgical applications, a fixed room imaging system for urology, as well as minimally invasive navigation and 3D visualization instrumentation. Together, GE Healthcare's ICS business is helping to make minimally invasive therapy a reality.
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