GE HealthCare

Compensation

Full Description

Job Description: • Develop, execute, and track remediation plans to address potential compliance gaps identified through due diligence, audits, or regulatory findings • Support remediation of legacy systems to meet compliance expectations • Partner with functions to lead remediation of Design History Files (DHFs), Technical Documentation, Risk Management Files, and labeling as required • Identifies critical path decisions, makes recommendations, and influences / gets buy-in from segment leadership and business process owners to maximize QMS integration, compliance and effectiveness • Provide clear communication of remediation status, risks, and timelines to leadership • Owns all project risk; including time and scope, and the associated plans to contain and/or mitigate risk • Coordinates Operational Reviews working across the organization to ensure targeted outcomes are achieved • Supports external and internal audit activity as needed Requirements: • Minimum of Bachelor's Degree in Engineering, Computer Science or equivalent • 6+ years working experience in the medical device industry and/or regulated industry • Demonstrated understanding or aptitude in Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485 • Masters Degree in Science or Business Administration (desired) • Experience working with Software as a Medical Device (SaMD) (desired) • Experience in integration of acquired businesses including remediation (desired) • Experience working and communicating directly with external medical device regulators (desired) • Experience in developing, implementing and maintaining quality system processes and driving improvements to processes (desired) • Strong oral and written communication skills (desired) • Strong interpersonal and leadership skills (desired) • Demonstrated ability to analyze and resolve problems (desired) • Demonstrated ability to lead programs / projects (desired) • Ability to document, plan, market, and execute programs (desired) • Established project management skills (desired) Benefits: • Medical insurance • Dental insurance • Vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life insurance • Disability insurance • Accident insurance • Tuition reimbursement