Senior Quality Engineer (Independent Contractor)

RapidAI • Golden, CO

9d • Onsite

About The Position

RapidAI is seeking an Independent Contractor to provide Senior Quality Engineering services at the forefront of medical device software development. This is a project-based engagement for approximately 3-6 months, requiring full-time hours (approx. 40 hrs/week). The role involves developing and implementing software quality standards, ensuring compliance with procedures, and providing Quality Assurance support for Software as a Medical Device (SaMD). Key responsibilities include reviewing product requirements, verification and validation deliverables, managing issue tracking, and supporting the validation of SaMD testing tools. The contractor will also support new product development activities using the Jama requirements management platform.

Requirements

• Bachelor of Science Degree.
• 5+ years of professional experience preferred.
• Mandatory background in Software Development.
• Strong project management skills.
• Results-driven approach.
• Ability to maintain accountability to strict project deadlines.

Nice To Haves

• Previous experience with Quality Management Systems (QMS).
• Experience with SaMD development under IEC 62304.
• Prior experience using Jama Connect for requirements and traceability.

Responsibilities

• Develop, implement, and maintain standards for software quality processes and procedures to support the software life cycle.
• Ensure that software project and process control documentation are compliant with established procedures.
• Provide Software Quality Assurance support for Research and Development and production of Software as a Medical Device (SaMD).
• Review product requirements for traceability, risk remediation, and testability.
• Review verification and validation deliverables for compliance with regulatory requirements.
• Manage and track software problem reports and deviations through to closure.
• Support the development, update, and validation of software utilized in SaMD testing.
• Support new product development activities specifically utilizing the Jama requirements management platform.

Benefits

• The selected individual is responsible for their own taxes, insurance, and equipment as applicable, and is not eligible for company-sponsored benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior