QA Manager

🕒 Yesterday

🇺🇸 United States – Remote

💵 $122.4k - $183.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Lead, coach, and develop Regional Quality team members supporting the U.S. market • Drive engagement, accountability, cross-functional collaboration, and Quality/compliance culture • Provide Quality leadership and governance for U.S. Regional Quality activities, primarily radiopharmaceutical products and distribution operations • Oversee the regional Quality Management System and alignment with Global QMS and U.S. regulatory requirements • Ensure compliance with FDA requirements, cGMP, GDP, product-specific controls, state requirements, and company Quality standards • Oversee product distribution lifecycle activities including receipt, storage, handling, transportation, distribution, returns, recalls, and disposition • Oversee time- and temperature-sensitive radiopharmaceutical distribution controls • Identify, assess, communicate, and escalate Quality and compliance risks • Provide Quality oversight for U.S. radiopharmaceutical distribution across operations, distribution locations, logistics providers, and outsourced activities • Oversee transportation, temperature excursions, distribution deviations, complaints, returns, recalls, and distribution-related Quality events • Partner with Supply Chain, Operations, Regulatory Affairs, Pharmacovigilance, Medical, Commercial, and other functions • Support qualification, monitoring, and governance of third-party logistics providers, distributors, suppliers, and external partners • Support Contrast Media distribution and Quality activities as needed • Establish and monitor Quality objectives, KPIs, trends, and performance metrics • Ensure investigation, documentation, approval, and closure of deviations, CAPAs, complaints, change controls, temperature excursions, and other Quality records • Drive corrective and preventive action effectiveness, issue trending, simplification, standardization, and continuous improvement • Participate in global and regional Quality initiatives and share best practices • Maintain inspection readiness and support regulatory inspections, internal audits, supplier/distributor audits, and Quality assessments • Represent Regional Quality in regulatory and external interactions • Ensure audit findings and nonconformities are investigated and corrective actions completed • Serve as senior Quality partner to U.S. Regional, Supply Chain, Operations, Regulatory, and Commercial leadership • Provide independent Quality oversight and escalate significant risks • Communicate Quality performance, emerging risks, inspection readiness, and significant Quality events to leadership

🎯 Requirements

• Master's degree from an accredited university or college; or bachelor's degree and 2 years of relevant experience; or high school diploma/GED with at least 6 years of relevant experience • Strong oral and written communication skills • Strong interpersonal and leadership skills • Ability to analyze and resolve problems • Ability to lead programs/projects • Ability to document, plan, market, and execute programs • Established project management skills • Legally authorized to work in the United States • GE HealthCare will not sponsor employment visas now or in the future • Successful completion of a drug screen, as applicable • May need to satisfy customer COVID-19 vaccination mandates

🏖️ Benefits

• Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI) • Medical, dental, and vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Relocation assistance not provided • Drug screen as applicable • Potential customer vaccination mandates may apply to certain employees

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