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.