Quality Professional

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.

• 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 – Plan and execute IQ/OQ/PQ activities for manufacturing processes, equipment, and test methods.
• Risk management – Support product risk assessments in accordance with ISO 14971, ensuring risk controls are implemented and verified.
• Supplier quality – Evaluate and monitor suppliers, conduct audits, and manage incoming inspection requirements.
• Change control – Assess and approve engineering changes, ensuring regulatory and quality impacts are fully understood.
• Internal auditing – Conduct internal audits and support external audits from notified bodies and regulatory authorities.
• Data analysis – Use statistical tools to monitor process capability, identify trends, and drive continuous improvement.
• Cross‑functional collaboration – Work closely with R&D, Manufacturing, Regulatory Affairs, and Operations to ensure quality is embedded throughout the product lifecycle.

• Degree in Engineering, Quality, or related discipline.
• Experience in a medical device, pharmaceutical, or other regulated manufacturing environment.
• Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and MDR/IVDR (as applicable).
• Proficiency with root‑cause analysis, statistical techniques, and validation methodologies.
• Excellent communication skills and the ability to influence across teams.
• Competence with QMS software and tools such as Minitab, JMP, or similar.

• Auditor certification (e.g., ISO 13485 Lead Auditor).
• Six Sigma Green Belt or higher.
• Familiarity with cleanroom manufacturing or sterile device requirements.