Quality Assurance Engineer

Evaluate Manufacturing and Quality processes for compliance with ISO 13485, GMP, and FDA 21 CFR 820.

Support Quality, Manufacturing and cross‑functional teams with investigations, documentation, and continuous improvement.

Support continuous improvement to manufacturing process through NCRs, root cause analysis and risk management activities.

Support internal audits.

Review/approve SOPs and product/equipment specifications.

Adhere to Quality Management System (QMS) requirements in line with Corin’s Good Manufacturing Practice (GMP) as per ISO13485 & FDA21 CFR Part 820.

Work with multiple stakeholders internally; R&D, Operations and Validation plus many others.

Analyse quality data, support product complaint investigations, and maintain Quality Dashboards/KPIs.

Experience in a highly regulated environment e.g. medical devices, pharma, aerospace, automotive.

Knowledge of upholding core Quality requirements within GMP environment.

Background in quality, engineering or with manufacturing experience. Degree or HNC/HND in Engineering beneficial (ideally mechanical or biomedical).

Hands‑on experience in a similar role with quality requirements.

Knowledge /understanding of core quality concepts such as of CAPA, NCRs, revision control, and root cause analysis .