Quality and Regulatory Engineer in Houghton-Le-Spring, Sunderland

Energy Jobline CVL; Houghton-le-Spring; On-site; GBP 35,000 - 42,000; Full time

Job summary

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.

Qualifications

• 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.

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 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.

Skills

Analytical thinking

Problem solving

Written & verbal communication

Education

Degree in Engineering, Life Sciences or related

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