Quality Professional
O
Omega Resource Group
📍 Middleyard, Gloucestershire, United Kingdom
Job Description
Role: Quality Professional
Day Shift
Gloucestershire
The Quality Engineer plays a central role in ensuring that all medical devices are designed, manufactured, and released in full compliance with ISO 13485, FDA 21 CFR Part 820, and all applicable regulatory and customer requirements. This role combines analytical problem‑solving, process optimisation, and cross‑functional collaboration to maintain the highest standards of product safety, reliability, and performance.
Key Responsibilities
Quality system ownership — Maintain and improve elements of the Quality Management System (QMS), ensuring alignment with ISO 13485 and FDA QSR requirements.
Non‑conformance management — Lead investigations into product and process non‑conformances, using structured problem‑solving tools (5 Whys, Ishikawa, DMAIC).
CAPA leadership — Drive Corrective and Preventive Actions from root‑cause analysis through to verification of effectiveness.
Process validation — P...
Day Shift
Gloucestershire
The Quality Engineer plays a central role in ensuring that all medical devices are designed, manufactured, and released in full compliance with ISO 13485, FDA 21 CFR Part 820, and all applicable regulatory and customer requirements. This role combines analytical problem‑solving, process optimisation, and cross‑functional collaboration to maintain the highest standards of product safety, reliability, and performance.
Key Responsibilities
Quality system ownership — Maintain and improve elements of the Quality Management System (QMS), ensuring alignment with ISO 13485 and FDA QSR requirements.
Non‑conformance management — Lead investigations into product and process non‑conformances, using structured problem‑solving tools (5 Whys, Ishikawa, DMAIC).
CAPA leadership — Drive Corrective and Preventive Actions from root‑cause analysis through to verification of effectiveness.
Process validation — P...