Quality Lead Specialist 2 – Healthcare Quality | Medical Device QMS | Design Control Compliance
Job ID: R4034139
Location: Bengaluru, Karnataka, India – 560066
Department: Healthcare Quality & Regulatory
Experience Required: 6+ Years (Regulated Industry Experience Mandatory)
Employment Type: Full-Time
Relocation Assistance: Not Provided
About the Company
GE Healthcare is a global leader in medical technology and digital healthcare innovation. The organization is committed to advancing healthcare without limits by delivering compliant, high-quality, and technology-driven medical solutions across global markets.
Role Overview
The Quality Lead Specialist 2 – Healthcare Quality is a mid-career, high-impact technical role responsible for ensuring Quality Management System (QMS) compliance across New Product Introduction (NPI) and Installed Base (IB) deliverables, including both software and hardware medical device products.
This role works closely with Product Engineering and cross-functional stakeholders to ensure Design Control compliance, regulatory alignment, and preventive quality assurance throughout the product lifecycle.
The position requires strong expertise in medical device regulations, quality systems, and failure analysis within a regulated healthcare environment.
Key Responsibilities
Drive and strengthen a proactive Quality culture across product lines, sites, or regions.
Ensure full compliance with regulatory requirements including ISO standards and global regulatory frameworks.
Lead and support Quality Management System (QMS) activities aligned with product development and lifecycle management.
Partner with engineering teams to ensure Design Control compliance for medical device software and hardware.
Conduct detailed failure analysis for nonconformances and lead CAPA investigations.
Develop and implement corrective, preventive, remediation, and retrospective action plans.
Monitor and report quality objectives, KPIs, and compliance metrics.
Represent the organization during external audits and regulatory interactions when required.
Utilize technical judgment and analytical problem-solving to resolve complex quality issues.
Provide guidance and informal mentorship to junior team members.
Support continuous improvement initiatives across processes and systems.
Required Qualifications
Minimum 6+ years of experience in Healthcare Quality within a regulated industry.
Strong experience working with ISO 13485, FDA regulations, and EU MDR/MDD frameworks.
Knowledge level comparable to a Bachelor’s degree from an accredited institution (or equivalent industry experience).
Proven experience in Design Control and Quality compliance for medical devices.
Hands-on experience in CAPA management and nonconformance investigation.
Preferred Skills & Regulatory Expertise
In-depth knowledge of:
FDA 21 CFR Part 820 (QSR)
ISO 13485 (Medical Device QMS)
IEC 62304 (Medical Device Software Lifecycle)
Strong analytical and root cause analysis capability.
Ability to explain complex technical concepts clearly to cross-functional stakeholders.
Experience supporting both software and hardware medical device products.
Excellent written and verbal communication skills.
Core Competencies
Regulatory compliance leadership
Medical device QMS expertise
Design Control and NPI quality oversight
Risk-based thinking and preventive quality approach
Cross-functional collaboration
Data-driven decision-making
Why Join GE Healthcare
Work with a globally recognized medical technology innovator
Contribute to high-impact medical device development programs
Exposure to advanced regulatory environments and global standards
Competitive compensation and comprehensive benefits
Inclusive and collaborative workplace culture
Equal Opportunity Statement
GE Healthcare is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, and business needs, without regard to race, religion, gender, age, disability, or any other legally protected characteristic.
This Quality Lead Specialist 2 – Healthcare Quality opportunity is ideal for experienced quality professionals seeking to advance their careers in medical device regulatory compliance, design control quality management, and healthcare product lifecycle excellence within a global organization.
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Mexico |northeastern :
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Uxbridge | Australia | Richmond Hill | Mississauga | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Italy |Lombardy :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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Bangkok |Israel :
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Sofia |Sweden :
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Warsaw |
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