Overview
Senior Software Quality Engineer Jobs in United States at Codon Partners
Title: Senior Software Quality Engineer
Company: Codon Partners
Location: United States
Senior Software Quality Engineer – Remote
Excited to be supporting a growing, innovation driven healthcare technology company developing software and AI enabled solutions designed to improve patient outcomes and accelerate clinical decision-making.
As the organization continues to scale its software and digital health capabilities, they are seeking a Senior Software Quality Engineer to support the development, validation, and ongoing compliance of regulated software products, including SaMD platforms and AI/ML-enabled technologies.
The Senior Software Quality Engineer will work closely with Software Engineering, Product Development, Regulatory Affairs, Cybersecurity, Clinical, and Data Science teams to ensure software quality, regulatory compliance, and adherence to industry standards throughout the Software Development Lifecycle (SDLC).
The ideal candidate will bring strong experience supporting regulated software products within medical device, diagnostics, digital health, or related healthcare environments, along with deep familiarity with software lifecycle standards and risk management principles.
Exposure to AI/ML enabled products and evolving regulatory expectations surrounding machine learning technologies is strongly preferred.
Key Responsibilities
- Partner with cross functional development teams to support software quality and compliance activities throughout the Software Development Lifecycle (SDLC)
- Support quality initiatives related to Software as a Medical Device (SaMD), digital health platforms, and AI/ML-enabled technologies
- Ensure alignment with applicable regulations and standards including:
- FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- IEC/ISO 62304
- IEC 82304-1
- Relevant cybersecurity and software assurance guidance
- Review and support approval of software development documentation including:
- Software Requirements Specifications (SRS)
- Design and architecture documentation
- Verification & Validation documentation
- Traceability matrices
- Risk management files
- CAPAs and change controls
- Participate in software risk management activities aligned with ISO 14971
- Support Design Control activities from early development through commercialization
- Collaborate with Regulatory Affairs teams in support of FDA submissions and global regulatory activities
- Support internal audits, supplier quality activities, and external inspections
- Contribute to validation and qualification activities for software systems and tools
- Provide quality oversight within Agile and DevOps development environments
- Support continuous improvement initiatives across the Quality Management System (QMS)
- Stay informed on evolving regulatory expectations related to AI/ML-enabled medical technologies, cybersecurity, and digital health products
- Mentor junior team members and contribute to software quality best practices across the organization
Qualifications
- Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, Software Engineering, or related technical discipline
- 5+ years of experience in Software Quality Engineering within medical device, diagnostics, digital health, biotech, or regulated healthcare environments
- Strong experience supporting Software as a Medical Device (SaMD) products
- Hands-on knowledge of:
- IEC/ISO 62304
- ISO 13485
- ISO 14971
- FDA Design Controls
- Software Development Lifecycle (SDLC) methodologies
- Experience supporting software verification & validation activities
- Familiarity with Agile, Scrum, and/or DevOps environments
- Experience participating in audits and regulatory inspections
- Strong communication and stakeholder management skills
- Ability to operate effectively within fast-paced, collaborative environments
