Quality Associate

PicturaBio; Oxford; On-site; GBP 26,000 - 38,000; Part time

Job summary

PicturaBio is building an early-stage QMS to underpin regulated IVD manufacture. The Senior Quality Associate will help develop and operate the eQMS (Greenlight Guru) and contribute to ISO 13485 compliance for UK and US regulation.

The role offers part-time hours (2-3 days per week) with potential to grow, and a clear path to Management Representative responsibilities as the QMS matures alongside the business. Location is Oxford, with pro rata competitive pay.

Qualifications

• Experience in quality role within IVD manufacturing.
• Demonstrated ability to manage suppliers and supplier quality.
• Hands-on with electronic quality management systems (eQMS).
• Knowledge of ISO 13485 and IVD regulatory frameworks.

Responsibilities

• Support development and maintenance of the eQMS (Greenlight Guru).
• Assist with Design Control processes and deliverables.
• Lead day-to-day supplier management activities and evaluations.
• Support risk management per ISO 14971.
• Maintain regulatory documentation and technical files.

Skills

IVD quality

Supplier management

eQMS

ISO 13485

Tools

Greenlight Guru

Job description

PicturaBio is developing an AI-enabled in vitro diagnostic (IVD) system that combines a wet-lab assay, microscopy imaging, and computer vision / machine learning analysis to deliver diagnostic results. As the company progresses toward non-clinical evaluation and commercial launch of its assay, it is building out the Quality Management System (QMS) that will underpin regulated IVD manufacture, both in the UK and in the US.

This is an opportunity to join at an early and formative stage, helping to shape the eQMS (Greenlight Guru) as the company scales, with a clear path to growing responsibility as the role and the business develop.

The Senior Quality Associate will support the development and day-to-day operation of PicturaBio's Quality Management System, with particular focus on:

• Supporting the design and development teams with Design Control processes and deliverables.
• Administration of the electronic QMS (eQMS).

The role is intended to grow in scope and hours alongside the business, with a route toward Management Representative responsibilities as the IVD system and QMS mature, if desired.

Key responsibilities

• Support the development, implementation, and ongoing maintenance of the eQMS (Greenlight Guru) in line with ISO 13485 and applicable IVD regulatory requirements (UK MDR 2002, EU IVDR, FDA).
• Support the development of Research Use Only products in the short-term, prior to conversion of these to full IVD regulated products over time.
• Lead day-to-day supplier management activities: supplier qualification, approval, evaluation, and ongoing performance monitoring for IVD component and material suppliers.
• Support risk management activities in line with ISO 14971, as required.
• Assist with maintaining regulatory documentation and technical file content relevant to Quality.
• Administer and maintain the eQMS, including document control, change control, training records and CAPA.
• Support internal audits and assist with preparation for external and notified body audits.
• Work closely with cross-functional teams (R&D, Regulatory, Operations) to embed quality practices as the assay and IVD system develop.
• Take on progressively greater responsibility over time, with a defined path toward the Management Representative role as the QMS and company mature if desired.

Experience and Skills

• Experience working within IVD manufacture, in a quality-facing role.
• Demonstrable experience of supplier management and evaluation within a regulated medical device or IVD environment.
• Hands-on experience working with an electronic Quality Management System (eQMS).
• Working knowledge of ISO 13485; awareness of ISO 14971 and IVD regulatory frameworks (UK MDR 2002, EU IVDR, and/or FDA pathways).
• Comfortable working autonomously and flexibly in a fast-moving, early-stage company environment.
• Experience supporting internal or external (including notified body) audits.
• Familiarity with risk management processes for medical devices/IVDs.
• Prior exposure to a company scaling from pre-commercial to commercial IVD manufacture.

Hours and Progression

This role is offered initially on a part-time basis of 2-3 days per week, with scope to increase hours over time as the IVD system moves through development toward commercial launch. There is a clear intention to grow the scope of the role, including a progression path toward the Management Representative position, as the QMS and the wider Quality function develop alongside the business.

Initially 2-3 days per week (part-time), with the potential to increase over time as the IVD system develops toward commercial launch.

Location: Oxford offices at Wood Centre for Innovation, Oxford OX3 8SB

Competitive, dependent on experience (pro rata)