QA Manager

🔥 18 hours ago

🏈 Ohio – Remote

🏈 Ohio – Remote

💵 $106.4k - $159.6k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 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

• Ensure QMS processes including Document Control, Complaint Management, Post-Market activities, CAPA, and Training meet applicable quality and regulatory standards • Write, update, and review quality documents, procedures, policies, and business processes for ongoing compliance • Assist and lead investigations of nonconformities and determine root causes using appropriate tools • Develop product knowledge to make informed decisions influencing product quality and safety • Support audits by promptly delivering complete and accurate records • Collaborate with stakeholders to track and monitor QMS process successes and pain points • Implement improvements to drive compliance, quality, and process efficiency • Participate in risk assessments, risk mitigation strategies, and risk management plans; provide review or approval as needed • Assist during supplier, critical supplier, notified body, and other audits • Stay current with guidance documents, regulatory requirements, and industry best practices • Assist in other QMS areas as directed by the manager • Ensure adherence to the MIM Software Quality System and the MIM/GE HealthCare Quality Management System

🎯 Requirements

• Bachelor's degree from an accredited university or college • At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD) • Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including FDA CFR 21 820, ISO 13485, and MDSAP • Demonstrated experience in leading and managing a team effectively • Demonstrated ability to collaborate effectively and resolve conflicts • Legal authorization to work in the U.S.; employment visa sponsorship is not available now or in the future • Proficient knowledge of MIM’s product portfolios and Primary Products and classifications • Experience with Document Control, Complaint Management, Post-Market activities, CAPA, and Training QMS processes • Knowledge of root cause analysis, risk assessments, risk mitigation strategies, and risk management plans • Ability to communicate quality and regulatory requirements to cross-functional teams • Critical thinking, problem-solving, root-cause analysis, and process improvement skills • Ability to manage multiple priorities and navigate change • Initiative, effective time management, and ability to work independently

🏖️ Benefits

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI) • 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 • Professional development • Relocation assistance not provided