Medical Device Quality & Regulatory Engineer (Maternity Cover)

Energy Jobline CVL; Houghton-le-Spring; Presencial; GBP 35.000 - 42.000; Jornada completa

Descripción de la vacante

Energy Jobline CVL is seeking a Quality and Regulatory Engineer for maternity cover based in Houghton Le Spring. Hours are 8.00am - 4.00pm, Monday to Friday, with potential shift changes to two shifts later.

You will support medical device regulatory affairs, maintain ISO 13485 QMS compliance, and drive CAPA and continuous improvement across manufacturing, QA documentation, and audits.

Formación

• Degree in Engineering, Life Sciences, or related discipline.
• Minimum 1 year of experience in medical device regulatory affairs, quality assurance or quality management systems.
• Experience supporting EU MDR and/or ISO 13485.
• Strong analytical and problem-solving skills.
• Good written and verbal communication skills.

Responsabilidades

• Support the design, development, manufacture, testing and regulatory compliance of medical devices and related products.
• Develop, implement and maintain effective quality control systems and processes.
• Create and manage production protocols, procedures and quality documentation.
• Ensure products meet quality, safety and regulatory requirements.
• Train and support production personnel in quality standards and procedures.
• Monitor quality performance and drive continuous improvement across manufacturing operations.
• Collect, analyse and report quality data to identify trends and opportunities.
• Investigate non-conformances and CAPA implementation.
• Troubleshoot quality issues to improve product performance and process capability.
• Assist QA Manager with regulatory affairs activities and audits.

Conocimientos

Analytical thinking

Problem solving

Written & verbal communication

Educación

Degree in Engineering, Life Sciences or related

Descripción del empleo

Energy Jobline CVL is seeking a Quality and Regulatory Engineer for maternity cover based in Houghton Le Spring. Hours are 8.00am - 4.00pm, Monday to Friday, with potential shift changes to two shifts later.

You will support medical device regulatory affairs, maintain ISO 13485 QMS compliance, and drive CAPA and continuous improvement across manufacturing, QA documentation, and audits.