Medical Device QA Engineer – Root Cause & CAPA

Kinetica; Wales; On-site; GBP 25,000 - 36,000; Full time

Benefits offered by this job

On-site parking

Healthcare benefits

Job summary

Kinetica in South Wales is seeking a Junior/Quality Engineer to support QA activities within a medical device manufacturing setting. The role involves investigating quality issues, supporting audits, and assisting with QMS maintenance to ensure compliance.

Ideal candidates have QA experience in the medical device field and knowledge of ISO 13485 and ISO 14971, with a hands-on approach to problem-solving and continuous improvement.

Qualifications

• Experience in QA or Quality Engineer within medical device manufacturing.
• Knowledge of ISO 13485 and ISO 14971 is required.
• Experience managing non-conformances and deviations, including investigations, root cause, and CAPA.

Responsibilities

• Investigates product quality and compliance issues, identifying root cause and implementing corrective actions.
• Assist with product complaint handling with Engineering and Operations teams.
• Provide hands-on support for quality issues to enable timely decisions.
• Support internal, supplier and external audits (notified bodies).
• Address non-conformances and assist with QMS maintenance.
• Assist reviews of sterilization validation protocols and reports.
• Contribute to continuous improvement initiatives to streamline systems and procedures.
• Support maintenance and calibration of equipment, including preventive measures.

Skills

Quality Assurance

Root cause analysis

CAPA

Audit support

Continuous improvement

Education

Medical device QA exposure

Job description

Kinetica in South Wales is seeking a Junior/Quality Engineer to support QA activities within a medical device manufacturing setting. The role involves investigating quality issues, supporting audits, and assisting with QMS maintenance to ensure compliance.

Ideal candidates have QA experience in the medical device field and knowledge of ISO 13485 and ISO 14971, with a hands-on approach to problem-solving and continuous improvement.