Quality and Regulatory Engineer

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.