Program Manager, Quality, Remediation
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: Illinois • United States
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Salary
💰 $142,400 - $213,600 per year
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
remediation planscompliance gapsDesign History FilesTechnical DocumentationRisk Management FilesMedical Device QMSFDA CFR 21 820ISO 13485Software as a Medical Devicequality system processes
Soft Skills
communication skillsinterpersonal skillsleadership skillsproblem-solvingproject managementinfluencingrisk managementcollaborationanalytical skillsplanning
Certifications
Bachelor's Degree in EngineeringBachelor's Degree in Computer ScienceMaster's Degree in ScienceMaster's Degree in Business Administration