Medical Device QA Engineer: Regulatory & Documentation

Welldoc; Columbia (MD); Sur place; USD 90 000 - 125 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

Résumé du poste

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.

Responsabilités

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

Connaissances

Experience with SDLC processes

FDA regulated product development

Attention to detail

Project management skills

Excellent communication

Formation

BS Degree in Mathematics, Computer Science or Engineering

Outils

JIRA

Confluence

Asana

Description du poste

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).