Junior Quality Engineer

Junior/ Quality Engineer – South Wales – Medical Device 

About the Company:

We are looking for an experienced medical device QA professional wanting to move into quality engineering or Quality Engineer to work at a medical equipment manufacturing company in the south Wales area.  

Responsibilities:

• 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.

Requirements:

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