Kinetica
Quality Engineer
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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 of 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.
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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.
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