Program Manager, Quality, Remediation

GE HealthCare • Chicago, IL

1d

About The Position

The Program Manager, Quality, Remediation role within Solutions for Enterprise Imaging (SEI) will be responsible for leading the assessment of newly acquired businesses and ensuring alignment of procedures to assure product safety, quality, and site compliance by driving business alignment to industry requirements, including remediation as required. 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.

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.

Nice To Haves

• Masters Degree in Science or Business Administration.
• Experience working with Software as a Medical Device (SaMD).
• Experience in integration of acquired businesses including remediation
• Experience working and communicating directly with external medical device regulators.
• Experience in developing, implementing and maintaining quality system processes and driving improvements to processes.
• Strong oral and written communication skills.
• Strong interpersonal and leadership skills.
• Demonstrated ability to analyze and resolve problems.
• Demonstrated ability to lead programs / projects.
• Ability to document, plan, market, and execute programs.
• Established project management skills.

Responsibilities

• 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.

Benefits

• 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.
• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager