Quality Systems Engineer

IntaPeople Limited; Cardiff; On-site; GBP 40,000 - 60,000; Full time

Job summary

A high-tech manufacturer is seeking a Quality Systems Engineer in Cardiff. You will ensure compliance with regulatory standards, conduct internal/external audits, and provide support and training on quality systems. The ideal candidate has qualifications in Science or Engineering and experience with Quality Management Systems in regulated industries. Strong analytical skills are essential for success in this role. Join a growing team that values quality and system efficiency.

Qualifications

• Qualification in Science, Engineering, Quality, or Lead Auditor (ISO 9000 series).
• Extensive experience managing data within a QMS in a regulated industry.
• Strong analytical and statistical skills.

Responsibilities

• Ensure compliance with regulatory standards, including CAPA and inspections.
• Conduct and manage internal and external Quality System audits.
• Provide supervisory support and conduct training for quality awareness.

Skills

Analytical skills

Statistical skills

Education

Qualification in Science, Engineering, Quality, or Lead Auditor (ISO 9000 series)

Tools

Quality Management Systems (QMS)

Job description

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.