Job Description & How to Apply Below
About Radformation
Radformation creates solutions that detect medical errors and save clinical time for clinicians with a focus in radiation therapy. Using advanced algorithms and optimization techniques, our solutions bring automation to cancer treatments. Currently, many safety checks and planning steps are manually completed. Our goal is to help automate these processes for a more efficient and safer healthcare environment.
Our software focuses on three key areas:
Time savings through automation
Error reduction through automated systems
Increased quality care through advanced algorithms and workflows
We are a fully remote, mission‑driven team united by a shared goal: to reduce cancer’s global impact and help save more of the 10 million lives it claims each year. Every line of code, every product release, and every conversation with our customers brings us closer to ensuring no patient’s treatment quality depends on where they live.
Why This Role Matters
This role will serve as a supervisor within the QARA function, providing oversight and guidance to strengthen communication, alignment, and execution across the team. As Radformation continues to scale, the QARA Operations Lead will coordinate key quality and regulatory deliverables, ensuring they stay aligned with product development timelines. You will work closely with the VP of Regulatory Affairs and cross‑functional partners to track progress, support design control activities, and maintain audit‑ready documentation across QARA.
Responsibilities Include
Organize and manage timely completion of QARA tasks, including CAPAs and DHF deliverables
Coordinate due dates, dependencies, and status updates to align QARA work with project schedules
Maintain team‑wide deliverable trackers with owners, due dates, and dependencies
Partner with deliverable owners to keep status current and identify risks early
Interface with project leaders, RA, and Quality teams to clarify ownership and elevate risks
Ensure QARA deliverables related to design control release timing are tracked by phase
Coordinate the transition to new DHF/DDS templates during QMSR implementation
Utilize eQMS and ALM systems to ensure deliverables are properly stored and audit‑ready
Analyze performance data, tools, and templates to identify operational improvements
Assist with international regulatory submissions and global conformity assessment needs
Coordinate the company‑wide CAPA system
Lead CAPA investigations, corrections, corrective actions, preventive actions, and effectiveness checks
Host CAPA CRB meetings and present CAPA content during internal and external audits
Conduct CAPA training as needed
Perform other QARA‑related duties as assigned (e.g., validation of QARA applications)
Required Experience
5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience
3+ years in a project management or technical leadership role
Experience working in a regulated agile development environment
Expert familiarity with medical device CAPA regulations and requirements
Familiarity with global medical device regulations (QSR/QMSR, MDD/CMDR/MDR)
Strong understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and related standards
Preferred Experience
Product development experience
Extensive experience with eQMS and ALM systems
Strong project management skills
Post‑market / adverse event evaluation and reporting experience
PMI certification
Who You Are
Clear communicator who works effectively across teams
Highly motivated with strong attention to detail
Adaptable and managing multiple deliverable‑driven projects
Strong ownership mentality and prioritization skills
Committed to improving patient safety and product quality
Analytical, organized, and proactive in identifying risks and opportunities
AI & Hiring Integrity
At Radformation we believe AI can be an incredible tool for innovation, but our hiring process is all about getting to know you—your skills, experience, and unique approach to problem solving. We ask that all interviews and assessments be completed without tools that generate answers in real time. This ensures a fair…
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