IVD Quality Assurance Specialist & QMS Administrator

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 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.