Remote Medical Device QA Engineer (FDA/ISO)

Entrada Ventures; United States; Remote; USD 120,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401k retirement plan with employer match

Flexible Time Off

Job summary

Entrada Ventures is seeking a mission-driven Software Quality Engineer to support quality assurance and regulatory compliance efforts. You will work closely with Product and Engineering teams to ensure product safety and effectiveness while leading risk management activities.

This remote role offers a competitive salary of $120,000 to $130,000, with various employee benefits including health insurance and a 401k plan with employer match.

Qualifications

• 5+ years of software product development experience in healthcare or medical devices.
• Proven ability to author Verification/Validation plans and reports.
• Experience with FDA regulations and medical device development.

Responsibilities

• Establish and maintain software quality assurance processes to ensure compliance with FDA regulations.
• Act as the Quality partner across Product, Engineering, and SQE teams.
• Lead risk management activities, including maintaining Risk Management files.

Skills

Risk management

Attention to detail

Cross-functional communication

Education

Bachelor’s Degree in Electrical Engineering, Computer Engineering, or related technical discipline

Tools

JIRA

Confluence

Propel (or similar eQMS)

Google Workspace

Job description

Entrada Ventures is seeking a mission-driven Software Quality Engineer to support quality assurance and regulatory compliance efforts. You will work closely with Product and Engineering teams to ensure product safety and effectiveness while leading risk management activities.

This remote role offers a competitive salary of $120,000 to $130,000, with various employee benefits including health insurance and a 401k plan with employer match.