Lead Specialist, Product Surveillance, Ultrasound at GE Healthcare

Wuxi, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, UltrasoundIndustries

Requirements

Quality knowledge combined with skills in Product Surveillance
In-depth knowledge of GE HealthCare’s Quality Management System and Product Surveillance activities, including complaint trending and CAPA
In-depth understanding of key business drivers and how Product Surveillance integrates with other teams
Engineering/quality experience and standards in post market product surveillance activities
Proven interpersonal skills for communicating with colleagues, Ultrasound business, upper-level leaders, and providing guidance to new team members
Technical expertise and judgement to solve problems, resolve issues within established procedures, and use multiple internal sources for decisions
Ability to request technical or clinical information from engineering, field service, clinical applications personnel, or end users/customers
Awareness and compliance with GE HealthCare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable regulations (e.g., 21CFR part 820.198, 803 (MDR), MDD/MDR, ISO 13485)

Responsibilities

Evaluate complaints from patient safety perspective and identify those requiring further evaluation according to global regulations
Manage risk by identifying product safety issues and triaging complaints for further investigation
Perform hazard evaluations
Perform complaint closure according to set criteria and monitor through quality metrics
Ensure on-time submissions of safety and regulatory reports to regulators
Provide objective evidence of complaint handling process through compliant documentation
Ensure zero repeat findings from previous internal and external audits within area of responsibility
Analyze data on patient safety and risk, ensuring compliance with applicable post-market regulations
Participate in skilled tasks such as complaint trending, in-depth data analysis, risk assessments, approval of complaint investigations (CAPA), communications with upper-level leaders, and leading projects
Ensure timely complaint trending analysis and complaint investigations
Support business during internal and external audits of GE HealthCare’s Quality Management System (QMS)
Communicate post-market metrics to business and site leaders
Execute timely complaint handling process using prior experience and acquired expertise
Handle simple data entry work requiring face value check and correction
Impact projects, processes, and procedures within post-market, often leading such projects
Identify areas of improvement and promote execution of standardized activities through participating in team, internal, and external audits
Manage time to complete tasks/duties based on changing situations
Be accountable for quality of own work and for meeting or exceeding team’s quality metrics

Skills

Product Surveillance

Complaint Handling

Regulatory Reporting

21CFR 820.198

21CFR 803

MDR

ISO 13485

Risk Assessment

CAPA

Hazard Evaluation

Quality Metrics

Data Analysis

Trending Analysis

QMS

Audits

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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