14+ years in software quality

Software quality, from code to compliance.

I enjoy untangling tricky software problems. My work in medical software brings together hands-on testing, engineering, quality, and regulatory expectations.

Open to roles in software quality engineering, V&V, and regulatory compliance, especially in medical software and healthcare AI.

Art Richter smiling, arms crossed, wearing a black polo

Quality across the lifecycle.

Experience

Good verification starts with understanding what changed.

My background in software QA and quality engineering includes medical devices, regulated medical software, and healthcare AI.

Aidoc
Senior Software QA & RA Compliance Specialist–Regulated medical software: QA/RA compliance, risk-based V&V, change impact, and release evidence.
ControlRad
QA engineering to QA leadership, project management & regulatory work– and – · about six years combinedTeam coordination, system testing, and regulated development.
Harmonic
Senior QA Engineer–Embedded software/hardware, integration testing, and end-to-end system behavior.
Philips Medical via Qualitest
CT/PET medical imaging testing and system-level quality.–
  • Technical practice

    System, integration, regression, and end-to-end testing across software and hardware. Test design, defect investigation, and troubleshooting.

    In my personal projects, I use Playwright and TypeScript for UI testing and browser automation, with Git and CI workflows.

  • Choose evidence that fits the risk

    Risk-based verification and validation, change-impact assessment, and requirements traceability. Understanding which test conditions and results support the decision.

  • Work through the lifecycle

    Software lifecycle processes, design controls, requirements, and design documentation. Keeping engineering changes and verification evidence in step.

  • Make quality a shared practice

    Regulatory Affairs, Quality Management Systems (QMS), and release readiness, working across engineering, Product, DevOps, QA/RA, and risk management.

Regulatory & quality expertise

These are frameworks I’ve worked with across roles, depending on the product and task.

Software lifecycle, risk & usability
IEC 62304 · ISO 14971 · IEC 62366-1
Quality systems & regulatory work
ISO 13485 · FDA / 21 CFR Part 820 · EU MDR 2017/745

Personal software, in progress.

I define the problem, use AI to help build it, and take responsibility for what I publish.

CheckQuest project artwork with a compass and exploration route

CheckQuest

I started CheckQuest to explore autonomous website testing and the challenge of producing meaningful, trustworthy evidence. It investigates selected clues and reports what the evidence supports, including what still needs human judgment.

CLI available from source. Desktop interface in development. Trust is the direction I’m building toward. I’m not claiming it’s there yet.

Read the CheckQuest source
NihilBits original project wordmark and geometric N symbol

NihilBits

Small tools for oddly specific problems.

I build as BootNihil, my personal development identity. NihilBits collects practical tools and experiments for my own workflows. First up: jd-rose-pine, a JDownloader theme installer with backup choices and download validation.

Browse the NihilBits toolbox