Senior Quality Engineer (Independent Contractor)
Team: Quality & Regulatory
Location: Golden, CO
Commitment: Full Time - Contractor
Workplace Type: hybrid
Salary:
- Reporting: Project alignment and deliverables will be reviewed by the Director of Quality Engineering.
- Supervision: This is an individual contributor engagement; the Contractor has no direct reports.
- Status: This is a business-to-business or independent contractor engagement. The selected individual is responsible for their own taxes, insurance, and equipment as applicable, and is not eligible for company-sponsored benefits.
- Engagement Type: Independent Contractor (Project-Based)
- Schedule: Full-time hours (approx. 40 hrs/week)
- Duration: 3–6 Month Term
- Location: On-site at Golden, CO office (Denver area) 2-3 days a week
Scope of Services
- Quality Frameworks: Develop, implement, and maintain standards for software quality processes and procedures to support the software life cycle.
- Compliance Oversight: Ensure that software project and process control documentation are compliant with established procedures.
- SaMD Support: Provide Software Quality Assurance support for Research and Development and production of Software as a Medical Device (SaMD).
- Technical Reviews: Review product requirements for traceability, risk remediation, and testability.
- Regulatory Compliance: Review verification and validation deliverables for compliance with regulatory requirements.
- Issue Tracking: Manage and track software problem reports and deviations through to closure.
- Tool & Test Validation: Support the development, update, and validation of software utilized in SaMD testing.
- Systems Integration: Support new product development activities specifically utilizing the Jama requirements management platform
Qualifications and Experience
- Educational Background: Bachelor of Science Degree.
- Technical Experience: 5+ years of professional experience preferred, including a mandatory background in Software Development.
- Specialized Knowledge: Previous experience with Quality Management Systems (QMS) and SaMD development under IEC 62304 is preferred.
- Platform Proficiency: Prior experience using Jama Connect for requirements and traceability is strongly preferred.
- Professional Skills: Strong project management skills , results-driven approach , and the ability to maintain accountability to strict project deadlines.
The Contractor is expected to possess the following professional background:
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