Position Details
About this role
This role involves leading software defect management activities, ensuring compliance with regulatory standards, and supporting verification and validation processes for medical device software.
Key Responsibilities
- Lead defect management activities
- Perform requirements analysis
- Develop test strategies
- Ensure regulatory compliance
- Support verification and validation
Technical Overview
Focuses on software quality assurance, defect tracking, verification and validation, and regulatory compliance within the medical device industry, utilizing tools like Perforce.
Ideal Candidate
The ideal candidate is a mid-level QA engineer with at least 4 years of experience in software defect management, verification, and validation within regulated industries such as medical devices. They should have strong knowledge of FDA and ISO standards and experience with embedded software testing.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in regulated medical device software, No knowledge of FDA or ISO standards, Less than 4 years of relevant experience
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