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.