Medical Device QA Engineer: Regulatory & Documentation

Welldoc; Columbia (MD); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

Job summary

A digital health company is seeking a Software Quality Engineer to work in Columbia, MD. The role involves supporting Quality Assurance activities for developing software as medical devices, ensuring compliance with FDA and ISO standards. Candidates should have 3+ years of experience in regulated environments and a BS degree in a relevant field. This full-time position offers a competitive salary with benefits including medical insurance and 401(k).

Qualifications

• 3+ years’ experience with FDA and ISO regulated product development.
• Experience with ISO 13485, ISO 14971, FDA QSR.
• Comfortable working in a fast-paced and agile environment.

Responsibilities

• Support Quality Assurance activities for product development.
• Contribute to document and change control processes.
• Ensure compliance with regulatory requirements.

Skills

Experience with SDLC processes

FDA regulated product development

Attention to detail

Project management skills

Excellent communication

Education

BS Degree in Mathematics, Computer Science or Engineering

Tools

JIRA

Confluence

Asana

Job description

A digital health company is seeking a Software Quality Engineer to work in Columbia, MD. The role involves supporting Quality Assurance activities for developing software as medical devices, ensuring compliance with FDA and ISO standards. Candidates should have 3+ years of experience in regulated environments and a BS degree in a relevant field. This full-time position offers a competitive salary with benefits including medical insurance and 401(k).