Position Details
About this role
Conducts risk and compliance audits of medical device software to ensure safety, regulatory adherence, and quality throughout the development lifecycle, supporting Abbott’s quality and regulatory objectives.
Key Responsibilities
- Audit medical device software
- Assess compliance with standards
- Identify risk gaps
- Support quality improvement
- Ensure regulatory adherence
Technical Overview
Performs technical audits of software risk management, validation, and quality systems for medical device software, utilizing industry standards and regulatory frameworks.
Ideal Candidate
The ideal candidate is a senior QA professional with extensive experience auditing medical device software, ensuring compliance with regulatory standards, and managing quality systems throughout the software development lifecycle.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with medical device software, No background in quality systems or compliance, Absence of relevant certifications, Inability to understand regulatory standards
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