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    • Solid operational experience in Quality within a regulated industry such as manufacturing, medical devices, pharmaceuticals, aerospace, automotive, or food and…
    • Experience within a regulated manufacturing environment, such as medical devices (ISO 13485), pharmaceuticals or similar.
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AI Specialist (Quality)
Ideagen
·
3.6
Ruddington Fields Business Park, 1 Mere Way, Ruddington NG11 6JS
Full-time
Apply on company site

Job details

Here’s how the job details align with your profile.

Job type

Full-time

Full job description

Role Purpose:

Location- Ruddington, Nottinghamshire


Level - Professional


Department - Product R&D


Working Pattern - Hybrid (three days a week in the head office)


Benefits - Benefits at Ideagen


Salary - To be discussed at next stage


Ideagen is building AI for regulated industries where correctness is non‑negotiable.


As an AI Quality Specialist, you’ll use your real‑world Quality experience to shape how AI systems understand, interpret, and respond to Quality management scenarios.


This role is designed for experienced Quality practitioners who have worked hands‑on with non‑conformances, CAPAs, audits, and regulatory scrutiny and now want to apply that expertise in a completely new way.


Rather than interpreting standards within a single organisation, you’ll help define what good and defensible Quality practice looks like for an AI platform used by thousands of Quality professionals across regulated industries. Your judgement will directly influence how models classify non‑conformances, assess CAPA effectiveness, interpret audit findings, and respond to regulatory questions.


AI expertise is not required. What matters is operational credibility, sound professional judgement, and the ability to evaluate decisions rigorously and consistently.


Responsibilities:
  • Applying annotation guidelines for Quality training data set by the AI Domain Lead, ensuring consistent and defensible labelling decisions
  • Labeling Quality datasets at scale, using practitioner‑level judgement to classify non‑conformances, evaluate CAPA plans, and categorise audit and supplier quality issues
  • Evaluating AI‑generated outputs against expert‑defined rubrics, identifying errors, gaps, or unsafe interpretations and clearly documenting what a correct response looks like and why
  • Testing AI capabilities against realistic and complex Quality scenarios, including ambiguous root causes, cross‑functional failures, and regulatory edge cases drawn from real experience
  • Contributing to Quality “red‑team” testing by identifying challenging scenarios, complex CAPA chains, and multi‑standard regulatory situations that stress‑test the model
  • Supporting the curation and validation of Quality regulatory reference materials to ensure accuracy, relevance, and traceability
  • Participating in calibration sessions with other specialists to maintain consistency, resolve interpretation differences, and uphold high evaluation standards
  • Working closely with AI engineers and product teams, translating practitioner feedback into actionable improvements in model behaviour
Skills and Experience:
  • Solid operational experience in Quality within a regulated industry such as manufacturing, medical devices, pharmaceuticals, aerospace, automotive, or food and beverage
  • Applied, working knowledge of ISO 9001:2015 and at least one sector‑specific standard (e.g. ISO 13485, AS9100, IATF 16949, or FDA 21 CFR Part 820), gained through real‑world use—not just training or exams
  • Hands‑on experience with non‑conformance management, CAPA investigation and review, and audit participation or preparation
  • Strong analytical and written communication skills, with the ability to clearly explain why an answer is incorrect and what a compliant, high‑quality response should look like
  • Comfortable working through large volumes of detailed evaluation work while maintaining accuracy and consistency
  • Confident applying professional judgement where standards require interpretation rather than checklist compliance
  • Willing to challenge plausible‑sounding but incorrect outputs, prioritising correctness and regulatory integrity
  • Interested in contributing to the development of AI for regulated environments, even if your background is not technical


About Ideagen


Ideagen is the invisible force behind many things we rely on every day - from keeping airplanes soaring in the sky, to ensuring the food on our tables is safe, to helping doctors and nurses care for the sick. So, when you think of Ideagen, think of it as the silent teammate that's always working behind the scenes to help those people who make our lives safer and better. Everyday millions of people are kept safe using Ideagen software. We have offices all over the world including America, Australia, Malaysia and India with people doing lots of different and exciting jobs.
We’re building a future-ready team, and AI is part of how we work smarter. If you're curious, adaptable and open to using AI to improve how you work, you’ll thrive at Ideagen!
What is next?


If your application meets the requirements for this role, our Talent Acquisition team will be in touch to guide you through the next steps.


To ensure a flexible and inclusive process, please let us know if you require any reasonable adjustments by contacting us at recruitment@ideagen.com. All matters will be treated with strict confidence.


At Ideagen, we value the importance of work-life balance and welcome candidates seeking flexible arrangements. If this is something you are interested in, please let us know during the application process. Enhance your career and make the world a safer place!


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