Manufacturing Change Coordinator at GE Healthcare

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, ManufacturingIndustries

Requirements

Bachelor’s/master’s degree in engineering disciplines (Electrical/Mechanical/Production/Industrial/Electronics/Electronics and Telecommunication/Medical Electronics/Bio Medical Engineering)
Sound knowledge/experience of medical device Quality Management System (QMS) ISO13485, FDA regulations and Design Change control process
Good communication skills (Oral/Written)
Effective multitasking and ability to deliver on time and with quality
Ability to work in a team with good Interpersonal skills
Hands on experience on Microsoft office applications
Experience: 7 ~10 years in Medical Device Industry
Desired: ISO auditor certification

Responsibilities

Act as the primary coordinator for manufacturing changes, collaborating with cross-functional teams to implement engineering and production modifications effectively for NPI's, Manufacturing Transfer and existing products
Ensure all changes are executed in alignment with Quality Management System (QMS) requirements and regulatory standards
Participate in global and local change control meetings, initiating actions and driving timely closure of change-related tasks
Lead local change control forums, guiding cross-functional teams to resolve issues and implement improvements
Spearhead the implementation of QMS practices at the site level and support regulatory audits focused on change control processes
Partner with local and global QA teams to manage nonconformities (NCs), conduct investigations, and implement corrective and preventive actions (CAPA)
Coach and mentor the Process Engineering team on QMS principles and change control procedures to build organizational capability

Skills

QMS

Change Control

CAPA

NPI

Process Engineering

Regulatory Compliance

Nonconformities

Engineering Change Management

Manufacturing Processes

Audits

Cross-functional Collaboration

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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