Job Title: Associate Specialist – Quality
Location: Bengaluru, Karnataka, India
Company: GE Healthcare
Job ID: R4036587
Employment Type: Full-Time
Relocation Assistance: Not Provided
Experience Required: Minimum 5+ Years
Education Required: Bachelor’s Degree in Engineering
Associate Specialist – Quality | Medical Devices & Life Sciences
GE Healthcare is seeking an experienced Quality professional to support and strengthen Quality Management Systems (QMS) within medical device manufacturing, repair, and refurbishment operations. This role is responsible for ensuring regulatory compliance, driving quality metrics, leading CAPA investigations, and improving manufacturing process efficiency in line with global quality standards.
This opportunity is ideal for quality assurance professionals with strong exposure to ISO 13485, FDA 21 CFR Part 820, ISO 14971, and medical device regulatory frameworks.
Role Overview
The Associate Specialist – Quality will develop, maintain, and improve systems, processes, and compliance mechanisms to ensure products meet internal and external regulatory standards. The role supports preventive quality assurance activities, audit readiness, supplier quality oversight, and continuous process improvements using data-driven methodologies.
The candidate must demonstrate expertise in medical device quality systems, risk management, validation protocols, and regulatory compliance within manufacturing environments.
Key Responsibilities
Quality Management System (QMS) Oversight
Drive compliance activities for assigned product lines, site, or region.
Support and maintain total quality management systems aligned with ISO 13485 and FDA QSR.
Monitor and report quality metrics, ensuring continuous improvement initiatives.
Represent GE Healthcare during internal and external audits.
Regulatory Compliance & Risk Management
Ensure adherence to ISO 13485, FDA 21 CFR Part 820, MDSAP, and ISO 14971 standards.
Apply risk management tools including FMEA and control plans.
Support regulatory inspections and maintain audit readiness documentation.
Manufacturing Quality & Process Validation
Provide daily quality oversight for medical device manufacturing repair and refurbishment operations.
Lead investigations for non-conformances and CAPA implementation.
Execute process validations including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
Improve yield and reduce defects through root cause analysis and corrective measures.
Supplier Quality & Change Management
Manage supplier qualification processes and supplier audits.
Support change control activities and document control systems.
Ensure validation and compliance of process changes.
Data-Driven Quality Improvement
Utilize Statistical Process Control (SPC), capability studies, and data analytics to strengthen product quality.
Apply Lean and Six Sigma methodologies to enhance process efficiency.
Monitor process performance indicators and identify improvement opportunities.
Collaboration & Mentorship
Work cross-functionally with manufacturing, engineering, regulatory, and operations teams.
Mentor junior quality team members and promote a culture of compliance and accountability.
Engage in technical discussions and problem-solving initiatives across departments.
Required Qualifications
Bachelor’s Degree in Engineering.
Minimum 5+ years of experience in Quality Assurance within Medical Devices, Pharma, or Life Sciences industry.
Strong knowledge of:
ISO 13485
FDA 21 CFR Part 820 (QSR)
ISO 14971 Risk Management
MDSAP requirements
Hands-on experience in:
Supplier qualification and audits
Change control and document control
Process validation (IQ/OQ/PQ)
CAPA management
Root cause analysis and problem-solving tools
Core Competencies
Expertise in Quality Management Systems (QMS).
Proficiency in CAPA processes and non-conformance investigations.
Strong analytical skills with experience in SPC and capability studies.
Lean/Six Sigma knowledge preferred.
Strong interpersonal and cross-functional communication skills.
Ability to resolve issues within defined procedures and escalate when necessary.
Work Environment
This is an onsite role based in Bengaluru, Karnataka, supporting manufacturing and quality operations.
About GE Healthcare
GE Healthcare is a global leader in medical technology and digital health solutions. The organization is committed to improving patient outcomes through innovation, regulatory excellence, and operational quality. With a strong emphasis on compliance, collaboration, and integrity, GE Healthcare provides a platform for professionals to contribute to life-changing healthcare advancements.
Equal Opportunity Statement
GE Healthcare is an Equal Opportunity Employer committed to inclusion and diversity. Employment decisions are made without regard to legally protected characteristics and in compliance with applicable regulations.
If you are an experienced Quality Assurance professional in medical device manufacturing seeking to contribute to regulatory excellence and operational quality improvement, apply now to join GE Healthcare in Bengaluru.
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