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Senior Quality Engineer

2 months ago


Neath Neath Port Talbot, United Kingdom IntaPeople: STEM Recruitment Full time

An innovative leader at the forefront of enhancing patient care worldwide are growing their Quality Systems team in Cardiff. As a Quality Engineer (we’re hiring for both Senior and Mid-level) you'll play a key role in managing and improving quality systems.

You will ensure compliance with regulatory standards, including CAPA, complaints, post-market surveillance, NCR, document control, inspections, and product release.
You will assist in interpreting EU and US regulatory requirements, and advise design and manufacturing teams to meet these standards during product development and manufacturing.
You will conduct and manage internal and external Quality System audits, and assist with second and third-party audits of ATL-UK.
Additionally, you will analyse data to provide system performance reports to management, review documentation to maintain regulatory compliance, and identify opportunities to enhance system efficiency. You will also provide supervisory support when needed and conduct training to maintain company-wide awareness of Quality System requirements

Qualification in Science, Engineering, Quality, or Lead Auditor (ISO 9000 series).
Extensive experience in QA/QS within the medical device or pharmaceutical industry.
Proficiency in MS Word, Excel, and MRP systems.
Please note this role requires 3 days a week visits to site in Neath - working from home twice a week.