Medical Device Quality & Regulatory Engineer (Maternity Cover)

KES Solutions UK Limited; Houghton-le-Spring; On-site; GBP 35,000 - 45,000; Full time

Job summary

KES Solutions UK Limited is seeking a Quality and Regulatory Engineer on a maternity cover basis in Houghton le Spring. The role supports regulatory compliance of medical devices, CAPA, and quality system improvements within a manufacturing environment.

You will liaise across design, production, and QA teams to ensure EU MDR and ISO 13485 adherence, maintain documentation, and drive continuous improvement initiatives. The position is office-based with potential shift implications.

Qualifications

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

Responsibilities

• 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 consistently meet quality, safety, and regulatory requirements.
• Train and support production personnel in the application of quality standards and procedures.
• Monitor quality performance and drive continuous improvement initiatives across manufacturing operations.
• Collect, analyse, and report quality data to identify trends and improvement opportunities.
• Investigate product non-conformances and customer complaints, implementing CAPA.
• Troubleshoot manufacturing and design-related quality issues to improve product performance and process capability.
• Conduct testing, inspection, and evaluation of medical devices and other products to verify compliance with specifications and performance requirements.
• Support validation and verification activities as required.
• Assist the Quality Assurance Manager with medical device regulatory affairs activities.
• Support compliance with EU MDR, ISO 13485, and other regulatory standards.
• Participate in internal and external audits and support audit readiness activities.
• Support Clean Room manufacturing operations and ensure compliance with quality and regulatory requirements.
• Contribute to continual improvement of the Quality Management System (QMS).

Skills

Analytical skills

Problem-solving

Written and verbal communication

Regulatory affairs knowledge

Education

Degree in Engineering, Life Sciences, or related discipline

Job description

KES Solutions UK Limited is seeking a Quality and Regulatory Engineer on a maternity cover basis in Houghton le Spring. The role supports regulatory compliance of medical devices, CAPA, and quality system improvements within a manufacturing environment.

You will liaise across design, production, and QA teams to ensure EU MDR and ISO 13485 adherence, maintain documentation, and drive continuous improvement initiatives. The position is office-based with potential shift implications.