Quality Engineer – Medical Devices | QA, CAPA & Root Cause

Kinetica; Wales; Presencial; GBP 27 000 - 36 000; Tempo integral

Resumo da oferta

Kinetica in South Wales is seeking a Junior/Quality Engineer to join our medical device quality team. You will support QA activities, investigate quality issues, and assist with CAPA initiatives to ensure regulatory compliance.

The role offers hands-on exposure to ISO 13485/14971 processes, non-conformances, audits, calibration and maintenance of quality systems, and continuous improvement across the site.

Qualificações

• Experience working in QA or as a Quality Engineer in the medical device manufacturing industry.
• Knowledge of ISO 13485 and ISO 14971.
• Experience managing non-conformances and deviations, including investigations, root cause, and CAPA.

Responsabilidades

• Investigates product quality and compliance issues, identifying root cause and implementing corrective actions.
• Assist with product complaint handling in collaboration with Engineering and Operations teams.
• Provide hands-on support for general and technical quality issues to enable timely decision-making across the site.
• Support internal, supplier, and external audits (e.g., notified bodies).
• Address non-conformances.
• Assist in the maintenance or the Quality Management System (QMS).
• Assist with reviews of sterilization validation protocols and reports.
• Assist with continuous improvement initiatives to streamline systems and procedures.
• Support compliant use of equipment maintenance systems, including preventive maintenance and calibration.
• Perform additional responsibilities as assigned by Management.

Conhecimentos

QA experience

Root cause analysis

CAPA

Audit support

Quality systems

Ferramentas

QMS

Descrição da oferta de emprego

Kinetica in South Wales is seeking a Junior/Quality Engineer to join our medical device quality team. You will support QA activities, investigate quality issues, and assist with CAPA initiatives to ensure regulatory compliance.

The role offers hands-on exposure to ISO 13485/14971 processes, non-conformances, audits, calibration and maintenance of quality systems, and continuous improvement across the site.