Quality And Regulatory Engineer

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

Quality and Regulatory Engineer

Our client, based in Houghton Le Spring, is recruiting for a Quality and Regulatory Engineer for a maternity cover. Hours are 8.00am - 4.00pm Monday to Friday but may shift to a two-shift system later on.

Key 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 appropriate corrective and preventive actions (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 applicable regulatory standards.
• Participate in internal and external audits and support audit readiness activities.
• Support Clean Room manufacturing operations and ensure compliance with applicable quality and regulatory requirements.
• Contribute to the continual improvement of the Quality Management System (QMS).

Required

• 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.

Desirable

• Experience writing technical and regulatory documentation.
• Six Sigma qualification or equivalent continuous improvement training.
• Experience within a medical device manufacturing environment.
• Experience supporting Clean Room production activities.
• Knowledge of CAPA, risk management, and validation activities