Quality Specialist I – Healthcare Quality
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Category: Healthcare Quality & Regulatory
Job ID: R4033475
Experience Required: 4–9 Years
Relocation Assistance: Not Provided
About GE Healthcare
GE Healthcare is a global leader in medical technology and digital solutions, committed to creating a world where healthcare has no limits. Our mission is to innovate healthcare by delivering advanced technologies, medical devices, and software solutions that improve patient outcomes worldwide. At GE Healthcare, every voice matters, every idea counts, and every contribution drives a healthier world.
Role Overview
The Quality Specialist I – Healthcare Quality will play a pivotal role in ensuring product quality, regulatory compliance, and process excellence across software and hardware medical devices. This position is responsible for implementing and maintaining quality systems, driving compliance initiatives, and supporting product development to meet internal standards and global regulatory requirements, including ISO 13485, FDA, and EUMDD/MDR.
This role combines technical expertise with process oversight, focusing on quality management, CAPA implementation, and regulatory alignment. The individual will work closely with engineering, product, and regulatory teams to ensure Design Control Quality Management System (QMS) compliance for New Product Introductions (NPI) and investigational products (IB).
Key Responsibilities
Drive a culture of quality by implementing compliance initiatives for assigned products, sites, or regions.
Manage the total Quality Management System (QMS) for the business unit and maintain key quality metrics.
Ensure products and processes meet regulatory requirements and customer expectations.
Conduct failure analyses, nonconformance investigations, and corrective/preventive actions (CAPA) to support continuous improvement.
Collaborate with cross-functional teams to ensure process effectiveness and efficiency in healthcare quality operations.
Support the development, review, and release of products in compliance with Design Control and QMS standards.
Provide guidance to junior team members and mentor new hires in quality processes and regulatory standards.
Serve as a liaison with external regulatory agencies, representing GE Healthcare and supporting inspections/audits.
Apply technical judgment and analytical skills to solve complex quality and compliance issues.
Prepare quality documentation, reports, and status updates for internal and external stakeholders.
Required Qualifications & Experience
Experience: 4+ years in a Quality or Healthcare Quality role in a regulated industry (medical devices, diagnostics, or pharmaceuticals).
Proven knowledge of regulatory standards and quality frameworks, including ISO 13485, FDA 21 CFR 820, IEC 62304-2006 (Medical Device Software), and EUMDD/MDR.
Education: Bachelor’s degree in Life Sciences, Engineering, Biomedical, or equivalent. High school diploma with significant relevant experience may be considered.
Demonstrated ability to analyze, resolve, and prevent quality issues in complex regulated environments.
Desired Skills & Competencies
Strong understanding of Medical Device QMS requirements and regulatory compliance.
Excellent oral and written communication skills, with the ability to convey complex quality information clearly.
Proactive problem-solving and decision-making capabilities.
Ability to work independently and collaboratively in cross-functional teams.
Strong attention to detail and adherence to timelines and regulatory standards.
Knowledge of CAPA, risk management, and design control processes.
Commitment to confidentiality and integrity in handling sensitive product and regulatory data.
Why Join GE Healthcare
Global Impact: Contribute to life-saving medical technologies used worldwide.
Career Growth: Opportunities to advance within Quality, Regulatory, and Product Excellence tracks.
Inclusive Culture: Work in a diverse and collaborative environment that values your contributions.
Rewards & Benefits: Competitive salary, flexible benefits, and support to unlock your professional potential.
GE Healthcare is an Equal Opportunity Employer, committed to diversity, equity, and inclusion. Employment decisions are made without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, protected veteran status, or other legally protected characteristics.
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