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