A high-tech manufacturer in the Cardiff area requires a Quality Systems Engineer to join their growing team. As a Quality Systems Engineer you’ll play a key role in managing and improving quality systems.
Key Responsibilities:
* 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.
* 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.
Knowledge/experience we’re most interested in:
* Qualification in Science, Engineering, Quality, or Lead Auditor (ISO 9000 series).
* Extensive experience managing data within a QMS (quality management systems) in a regulated industry (aerospace, automotive, medical etc.)
* Strong analytical and statistical skills.
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