Description

You will ensure software quality compliance for Class II and Class III medical devices in Ann Arbor, MI.

Responsibilities

• Review software documentation including requirements, design documents, test plans, protocols, and reports.
• Execute feedback loops for test case initial reviews and corrections.
• Participate in formal code reviews and design reviews.
• Perform regression, impact, and dependency analysis.
• Manage software configuration and document control processes.

Required Skills

• 5+ years of experience as a Software Quality Engineer.
• Extensive knowledge of IEC-62304 and FDA guidelines for medical devices.
• Deep understanding of the Software Development Life Cycle (SDLC).
• Experience with ALM and SCM tools such as Helix and Surround.
• Expertise in software configuration management and documentation control.
• Experience participating in design and code reviews.
• Background in reviewing software testing lifecycles.
• Degree in any graduate field.

Key Skills

Education

Any Graduate