At a Glance
- Tasks: Support the design and compliance of medical devices while driving quality improvements.
- Company: Dynamic company in Houghton-Le-Spring focused on innovative medical solutions.
- Benefits: Competitive salary, supportive team environment, and opportunities for professional growth.
- Other info: Join a collaborative team dedicated to continuous improvement and regulatory excellence.
- Why this job: Make a real difference in healthcare by ensuring product quality and safety.
- Qualifications: Degree in Engineering or Life Sciences with experience in quality assurance.
The predicted salary is between 42750 - 52250 £ per year.
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
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Quality and Regulatory Engineer in Houghton-Le-Spring, Sunderland employer: Energy Jobline CVL
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We think you need these skills to ace Quality and Regulatory Engineer in Houghton-Le-Spring, Sunderland
Quality Control Systems
Regulatory Compliance
ISO 13485
EU MDR
Analytical Skills
Problem-Solving Skills
Communication Skills
