Quality Assurance Leader – Healthcare
Company: GE Healthcare
Location: Bengaluru, Karnataka, India
Job Type: Full Time
Experience Required: 10+ years in Quality Assurance within the healthcare or medical device industry
Job ID: R4036056
Role Overview
GE Healthcare is seeking a Quality Assurance Leader to drive excellence in quality management systems, compliance, and program execution for healthcare products. This role focuses on establishing a robust quality culture, ensuring regulatory compliance, and integrating quality processes across cross-functional teams globally. The ideal candidate will possess expertise in Design Controls, verification and validation, risk management, and CAPA implementation for new product introductions (NPI) and ongoing programs.
Key Responsibilities
Lead the Quality Assurance function for assigned products, sites, or regions, driving compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, IMDR, and other relevant regulations.
Develop and maintain robust quality systems, processes, and procedures to meet internal and external standards.
Partner with engineering and program teams to ensure proper Design Controls, including verification, validation, design transfer, and design change management.
Oversee review and approval of packaging specifications, test reports, and validation protocols.
Ensure audit readiness for internal, external, and regulatory inspections.
Apply risk management tools to evaluate and mitigate potential quality issues and deviations.
Support cross-functional teams in achieving program-level Quality and QMS deliverables.
Provide leadership, guidance, and informal mentoring to junior QA team members.
Champion continuous improvement initiatives to enhance process efficiency, compliance, and product quality.
Required Qualifications and Experience
Bachelor’s degree in Engineering with a minimum of 10 years of experience in Quality Assurance within the healthcare or medical device industry.
Specialist knowledge in Design Controls, validation and verification, change management, risk management, and CAPA processes.
Hands-on experience reviewing and approving packaging specifications, test reports, and validation protocols.
Proven ability to operate in a global matrix organization, collaborating effectively across regional and functional teams.
Strong leadership, communication, collaboration, and problem-solving skills.
Experience in the application of QMS and compliance requirements, including ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, and IMDR.
Preferred Skills
Experience with ISO/MDSAP audits, FDA inspections, and Notified Body audits.
Professional certifications such as ASQ, Six Sigma, or Lean Manufacturing.
Customer-focused, results-oriented mindset with demonstrated analytical and negotiation skills.
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, age, disability, or other legally protected characteristics. Employees are expected to uphold integrity, transparency, and ownership while fostering collaboration and high performance.
Additional Information
Relocation Assistance: Yes
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