Medical Device Software QA Engineer - CI/CD & Regulatory

DeBellis Catherine & Morreale - Corporate Staffing; Town of Tonawanda (NY); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Tuition assistance

Disability insurance

401(k)

Job summary

A staffing agency specializing in medical device roles seeks a Software Quality Assurance Engineer to ensure compliance with industry standards and regulations. The ideal candidate will have a Bachelor's degree and at least 3 years of experience in QA for embedded systems within regulated industries. Responsibilities include overseeing bug tracking, collaborating with teams for software fixes, and writing test plans. Competence in Python and familiarity with FDA submissions is essential. This role offers a competitive salary range of $110,000–$120,000 plus a 10% bonus.

Qualifications

• Minimum of 3 years of experience in QA for embedded systems in regulated industries.
• Strong background in software engineering and medical device regulations.
• Familiarity with FDA 510(k) submissions and IEC 62304 standards.

Responsibilities

• Oversee bug tracking and verification documentation.
• Collaborate with development teams for software issue resolution.
• Write and execute comprehensive test plans for software validation.

Skills

Quality Assurance

Embedded Systems

CI/CD

Python

Regulatory Standards Knowledge

Analytical Skills

Education

Bachelor’s degree in Computer Science or related field

Tools

Linux

CI/CD Tools

Job description

A staffing agency specializing in medical device roles seeks a Software Quality Assurance Engineer to ensure compliance with industry standards and regulations. The ideal candidate will have a Bachelor's degree and at least 3 years of experience in QA for embedded systems within regulated industries. Responsibilities include overseeing bug tracking, collaborating with teams for software fixes, and writing test plans. Competence in Python and familiarity with FDA submissions is essential. This role offers a competitive salary range of $110,000–$120,000 plus a 10% bonus.