Quality Lead Specialist 2 – Healthcare Quality
Company: GE Healthcare
Location: Bengaluru, Karnataka, India
Job Type: Full Time
Experience Required: 6+ years in Quality & Healthcare Quality within regulated industries
Job ID: R4034139
Role Overview
GE Healthcare is seeking a Quality Lead Specialist 2 to drive quality and regulatory compliance for both hardware and software medical device products. This role ensures that projects meet regulatory requirements, internal standards, and customer expectations. The position works closely with product engineering teams to support New Product Introduction (NPI) and Investigational Builds (IB), providing technical oversight and ensuring adherence to Design Control Quality Management System (QMS) processes.
Key Responsibilities
Develop and maintain quality systems, processes, and rules to meet internal and external regulatory requirements.
Drive a culture of quality by ensuring compliance across products, sites, and regions, while monitoring key quality metrics.
Support continuous product and process improvement through detailed failure analysis, nonconformance investigation, and corrective and preventive actions (CAPA).
Ensure all projects are executed in alignment with regulatory standards such as ISO 13485, FDA 21 CFR 820, IEC 62304, and EU MDR.
Serve as a subject matter expert within the discipline, providing guidance to team members and sharing technical expertise.
Communicate effectively with internal teams and, where relevant, serve as the technical interface with external stakeholders.
Apply professional judgment and analytical thinking to solve technical and regulatory challenges.
Contribute to the documentation, reporting, and execution of quality objectives, ensuring compliance with operational standards.
Required Qualifications and Experience
Minimum 6 years of experience in Quality Assurance or Healthcare Quality in a regulated industry such as medical devices.
Thorough knowledge of regulatory standards and QMS requirements including ISO 13485, FDA 21 CFR 820, IEC 62304, and EU MDR.
Equivalent to a Bachelor’s degree from an accredited university or college; relevant professional experience may substitute for formal education.
Demonstrated ability to execute quality strategies, analyze complex issues, and implement effective corrective actions.
Preferred Skills
Strong oral and written communication skills.
Experience in problem-solving and root cause analysis within a regulated healthcare environment.
Knowledge of software and hardware product lifecycle management in medical devices.
Ability to work collaboratively across cross-functional teams and contribute to process improvement initiatives.
Inclusion and Diversity
GE Healthcare is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or other legally protected characteristics. Employees are expected to embody integrity, transparency, and ownership while fostering a collaborative, high-performing work culture.
Additional Information
Relocation Assistance: Not Provided
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