Software Quality Engineer

Job Summary

A company is looking for a Specialist Engineer, Software Quality.

Key Responsibilities

• Lead Quality Engineering activities for software and hardware product development teams
• Develop and maintain Risk Management Files and Design History Files, ensuring quality oversight and approval of product development plans
• Collaborate with cross-functional teams on software quality, code reviews, and statistical analyses for design verification and validation

Required Qualifications and Education

• 8+ years of progressive Software Engineering experience in the medical device industry
• B.S./M.S. in a relevant engineering field or equivalent scientific degree
• Experience with FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366
• Experience in design, development, verification, validation, and testing of medical device hardware and software
• Proficient in statistical analysis and experience with quality engineering tools for design and process improvement