Manufacturing Process and Product Quality at GE Healthcare

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical TechnologyIndustries

Requirements

Engineering Degree in Electronics & Communication or Mechanical Engineering
9 to 12 years of experience in Healthcare industries (Process & product quality preferred)
Advanced experience in Manufacturing & Manufacturing Engineering Specialist (knowledge level comparable to Bachelor's degree with at least 9+ years of experience)
Good oral and written communication skills
Demonstrated ability to analyze and resolve problems
Ability to document, plan, market, and execute programs
Established project management skills

Responsibilities

Ensure medical devices meet the highest standards of safety, efficacy, and regulatory compliance
Lead quality strategy across the product lifecycle, from development through commercialization and post-market surveillance
Collaborate closely with cross-functional teams including Engineering, manufacturing, and regulatory affairs
Define and maintain product-specific quality plans
Oversee risk management activities such as FMEA and ensure robust control strategies are in place
Lead investigations into non-conformances and drive corrective and preventive actions (CAPA)
Ensure readiness for regulatory inspections and audits
Foster a culture of quality and continuous improvement using data-driven insights and quality metrics
Serve as the quality voice in regulatory submissions, ensuring alignment with global standards such as ISO 13485 and FDA QSR
Develop in-depth knowledge of a technical discipline and execute policy/strategy using prior experience
Use in-depth understanding of key business drivers and team integration to accomplish work
Use judgment to propose solutions outside set parameters (with guidance) and solve straightforward tasks
Provide informal guidance to new team members (as an individual contributor or early people leader)

Skills

Manufacturing Engineering

Process Quality

Product Quality

Electronics Engineering

Mechanical Engineering

Healthcare Manufacturing

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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