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 equivalen...