Senior Program Manager, Quality
Company: GE Healthcare
Location: Bengaluru, Karnataka, India
Job Type: Full Time
Experience Required: Minimum 10 years in Quality Assurance within Healthcare / Medical Devices
Job ID: R4035946
Role Overview
GE Healthcare is seeking a Senior Program Manager, Quality to lead quality initiatives, maintain compliance systems, and ensure products and projects meet internal and external standards. The role drives a culture of quality across assigned product lines, sites, or regions, integrating regulatory requirements, industry best practices, and process improvement strategies. This position collaborates with regional and global teams to enhance operational efficiency, mitigate risks, and maintain a robust Quality Management System (QMS).
Key Responsibilities
Develop, implement, and maintain quality systems, rules, and processes to meet internal and regulatory requirements.
Drive a quality culture through compliance initiatives, quality metrics, and reporting across assigned products, sites, or regions.
Ensure regulatory compliance with Design Controls and Quality standards, including ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, and IMDR.
Represent GE Healthcare to external agencies and stakeholders regarding quality and regulatory matters.
Provide guidance and mentorship to junior team members, fostering skills development and consensus-building within the team.
Lead low- to medium-risk projects, applying judgment to resolve day-to-day quality challenges and proposing innovative solutions.
Collaborate across internal departments and limited external sources to support data-driven decisions and continuous improvement.
Monitor quality objectives, performance metrics, and corrective actions to ensure process effectiveness and efficiency.
Required Qualifications and Experience
Bachelor’s degree in Engineering or related discipline.
Minimum 10 years of professional experience in Quality Assurance within the Healthcare or Medical Device industry.
Proven expertise in the application of QMS and regulatory compliance requirements for medical devices.
Strong understanding of ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, and IMDR standards.
Demonstrated leadership, collaboration, negotiation, and communication skills.
Experience working effectively in matrix organizations with regional and global teams.
Strong analytical and problem-solving abilities, with a customer-centric mindset.
Preferred Skills
In-depth knowledge of Medical Device Quality Management Systems and regulatory requirements.
Ability to analyze complex issues, resolve problems, and implement corrective/preventive actions.
Experience with cross-functional projects, process improvement initiatives, and quality audits.
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, protected veteran status, or other legally protected characteristics. Employees are expected to demonstrate GE Healthcare behaviors: humility, trust-building, transparency, focus, ownership, and integrity.
Why GE Healthcare
Joining GE Healthcare offers the opportunity to contribute to world-changing healthcare solutions. You will work within a collaborative, inclusive, and supportive environment with global exposure, career growth, and opportunities to influence quality across products and regions.
Additional Information
Relocation Assistance: Not Provided
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