GE HealthCare · 14 hours ago
QA Specialist
Boston, MA
Full-time
Onsite
Mid Level
4+ years expGE HealthCare is a leading global medical technology and digital solutions innovator. The QA Specialist II will support Document Control, CAPA system, Risk Management, and QMS activities to ensure compliance with FDA and ISO regulations, playing a critical role in maintaining product quality and safety.
AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical
No H1B
U.S. Citizen Only
Responsibilities
Support and lead QMS activities related to Document Control, QMS management, CAPA, Risk Management and Complaints
Lead and Implement improvements to drive compliance, quality, and efficiency of these processes
Investigate nonconformities and use appropriate tools to determine the root cause
Develop product knowledge to make informed decisions that influence product quality and safety
Support audits by promptly delivering complete and accurate records
Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes
Implement improvements to drive compliance, quality, and efficiency of these processes
Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed
Determine compliance of processes and regulations. Supports efforts to ensure the organization operates within established policies/procedures and complies with all applicable governmental regulations, both domestic and foreign
Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)
Proficient knowledge of MIM’s product portfolios and Primary Products and classifications
Stay current with the latest guidance documents, regulatory requirements, and industry best practices
Assist in other areas of the QMS as directed by the manager
Qualification
Required
Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of relevant work experience)
At least 4 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 but not limited to FDA CFR 21 820, ISO 13485, and MDSAP
Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available
Preferred
Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field
Demonstrated expertise in root cause analysis
Strong influencing skills and ability to clearly communicate the requirements to cross-functional teams
Demonstrated ability to collaborate effectively and resolve conflicts
Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills
Proficiency in managing multiple priorities effectively
Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills
Benefits
Professional development
Challenging careers
Competitive compensation
Company
GE HealthCare
GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.52BKey Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B
Leadership Team
Catherine Estrampes
President and CEO, US & Canada
Luiz Verzegnassi
President & CEO, Services
Recent News
Medical Device Network
2026-02-03
legacy.thefly.com
2026-02-02
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