Senior Lead Specialist Quality at GE Healthcare

Bengaluru, Karnataka, India

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical TechnologyIndustries

Requirements

Bachelor's degree from an accredited university or college with at least 7+ years of experience in Quality assurance domain
Advanced experience in the Quality & Healthcare Quality domain (knowledge level comparable to a Bachelor's degree from an accredited university or college)
Working experience in computer system and software validation

Responsibilities

Creates a Quality culture by driving compliance activities around a specific product, site or region
Responsible for the total quality management system for the business and driving Quality metrics
Ensures quality and regulatory compliance while driving process effectiveness and efficiency
Represents GE Healthcare to external agencies and champions the evolution of the quality culture
Executes and drives quality objectives, metrics, reporting and operating mechanisms
Develops in-depth knowledge of a discipline and uses prior experience and acquired expertise to execute functional policy/strategy
Communicates with direct colleagues and the business about design and coordination services rendered
Provides informal guidance to new team members and explains complex information to others in straightforward situations
Impacts projects, processes and procedures in own field, operating with some autonomy but focused on execution within standard functional practices
Utilizes technical expertise and judgement to solve problems, leveraging technical skills and analytic thinking, and may use multiple internal sources outside of own team to arrive at decisions
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements
Ensures that projects and products are capable and will meet specified standards (Preventive)

Skills

Key technologies and capabilities for this role

Quality ManagementRegulatory ComplianceTotal Quality ManagementQuality MetricsProcess ImprovementISO StandardsAuditingRisk ManagementCAPAFMEA

Questions & Answers

Common questions about this position

What qualifications are required for the Senior Lead Specialist Quality role?

A Bachelor's degree from an accredited university or college with at least 7+ years of experience in the Quality assurance domain is required. The role also requires advanced experience in Quality & Healthcare Quality and working experience in computer system and software validation.

What are the desired characteristics for this position?

Desired characteristics include knowledge of ISO13485 and regulatory standards such as FDA 21 CFR Part 11 compliance applicable for IT, CSV, and SDLC in the medical device industry.

What is the employment type for this job?

The position is full-time.

What does the company culture emphasize at GE Healthcare?

GE Healthcare emphasizes creating a Quality culture, inclusion and diversity, where every voice makes a difference, and is an Equal Opportunity Employer.

What salary or compensation is offered for this role?

This information is not specified in the job description.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free