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Senior Quality Assurance Manager - SAMD AI

Senior Quality Assurance Manager - SAMD AI

Toku Inc.Auckland, Auckland, New Zealand
17 hours ago
Job description

Senior Quality Assurance Manager – Toku Eyes

5 days ago Be among the first 25 applicants

Eligibility requirement : Applicants must already hold the right to work in New Zealand without time limits; sponsorship is not available for this role.

Join the team turning the eye into a window to human health.

Toku Eyes is a world‑leading AI health company using retinal images to reveal systemic health risks — from cardiovascular disease to kidney disease and biological aging. Our AI‑powered software‑as‑a‑medical‑device (SaMD) products, including CLAiR and MyKidneyAI, are transforming how preventive healthcare is delivered globally. We’re FDA Breakthrough‑designated, ISO 13485‑certified, and on a mission to make early detection accessible to everyone.

We’re now looking for a Senior Quality Assurance Manager to help us scale that mission across global markets — bringing energy, rigor, and leadership to our Quality System as we grow from cutting‑edge research into full‑scale commercialization.

You’ll lead the quality function at the intersection of AI innovation, clinical evidence, and regulatory excellence. Reporting to the Chief Compliance & Ethics Officer, you’ll own and evolve Toku’s ISO 13485‑compliant QMS — ensuring our products, processes, and people meet the highest global standards (FDA, MDR, UKCA, and beyond).

You’ll be both hands‑on and strategic : equally comfortable auditing a supplier, mentoring a QA associate, or advising leadership on risk‑based approaches to compliance in AI.

  • Lead, maintain, and continuously improve Toku Eyes’ ISO 13485 : 2016 QMS, ensuring alignment with FDA QMSR, MDR, and SaMD‑specific requirements.
  • Oversee design control, risk management (ISO 14971), software lifecycle compliance (IEC 62304), and cybersecurity documentation (FDA 2023 guidance).
  • Drive internal and supplier audit programs, CAPA effectiveness, and inspection readiness.
  • Partner with R&D, Clinical, and Regulatory teams to embed quality into every phase of product development and deployment.
  • Serve as management representative for quality during FDA, notified body, and partner audits.
  • Mentor and grow a small QA team; support training, process ownership, and culture of continuous improvement.
  • Champion data integrity, traceability, and usability compliance across our AI‑driven software ecosystem.
  • Collaborate globally with Topcon Healthcare (strategic partner) and external CROs to align on QA expectations and regulatory deliverables.

What You Bring

  • 7+ years in Quality Assurance within medical devices or SaMD, with at least 3 years in a lead or managerial role.
  • Proven experience managing QMS audits, CAPAs, and design controls.
  • Strong working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and FDA 21 CFR 820 / Part 11.
  • Understanding of AI / ML or digital health environments is a strong advantage.
  • Excellent communicator — you can translate standards into meaningful actions for teams across science, software, and operations.
  • A proactive, curious, and collaborative mindset — you thrive in dynamic, purpose‑driven teams.
  • Work on life‑changing AI technology that detects disease risk through the eye.
  • Join a team recognized by the FDA Breakthrough Devices Program.
  • Collaborate globally with experts in AI, clinical research, and medical regulation.
  • Enjoy flexible work, growth opportunities, and a culture built on innovation and integrity.
  • Be part of a company where your work genuinely impacts millions of lives.

    • Ready to look into the future of health?

    Apply now and help shape how the world sees disease prevention.

    Seniority level : Mid‑Senior level

    Employment type : Full‑time

    Job function : Quality Assurance

    Industry : Medical Equipment Manufacturing

    Location : Auckland, New Zealand

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    Quality Manager • Auckland, Auckland, New Zealand