Senior Associate Specialist, Quality
GE HEALTHCARE · Posted Oct 14
Medical technology, pharmaceutical diagnostics, and digital health solutions provider
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About the role
GE HealthCare is a global medical technology and digital solutions innovator whose purpose is to create a world where healthcare has no limits. The Quality function develops and maintains systems, rules, and processes to ensure fulfillment of internal and external requirements so that projects and products meet specified standards. This role drives compliance activities and the quality management system for a specific product, site or region, working with medical device software standards such as ISO 13485, ISO 14971 and IEC 62304.
What you will do
- Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. You will ensure quality and regulatory compliance while driving process effectiveness and efficiency.
- Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills.
- Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.
- May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters.
- A job at this level requires good interpersonal skills. Explains technical information to others.
- Candidate should have an awareness of Software Development Methodologies, Computer system validations.
- Knowledge of ISO 13485 standards , ISO 14971 standards, IEC 62304 and medical device regulations.
Skills used in this role
What the employer is looking for
- Bachelor's degree from an accredited university or college
- Minimum 5+ Years of relevant experience.
Preferred qualifications
- Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
- Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA(Food and Drug Administration) 21 CFR( Code of Federal Regulations) 820, IEC (International Electrotechnical Commission) 62304-2006 (Medical Device Software), and ISO 13485.
Benefits and support
- Compensation and benefits are detailed in the job posting
About GE HEALTHCARE
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator dedicated to providing integrated solutions, services, and data analytics. Spun off from General Electric, the company serves patients and healthcare providers globally through its advanced imaging, ultrasound, patient care solutions, and pharmaceutical diagnostics segments. It focuses on driving precision care, improving hospital efficiency, and advancing clinical outcomes worldwide.
- Industry
- Medical Devices
- Company size
- 54000 employees
- Founded
- 2023
- Location
- Chicago, Illinois, USA
- Funding stage
- Public Company
Funding
Public Company
Leadership
President and Chief Executive Officer
Chief Financial Officer
Chief Science and Technology Officer
General Counsel & Corporate Secretary
Global Chief AI Officer
Recent coverage
Business Wire
GE HealthCare Announces Executive Team and Operational Updates to Enhance Execution, Accelerate Innovation, and Drive Growth2026-04-29
GE HealthCare News
GE HealthCare Reports First Quarter 2026 Financial Results2026-04-29
NZ Herald
GE HealthCare Bets Big on Medical Imaging2026-09-28