At a Glance
- Tasks: Ensure medical devices meet quality and regulatory standards while supporting compliance activities.
- Company: Dynamic manufacturing business in Durham focused on medical devices.
- Benefits: Gain valuable experience in a regulated environment with potential for career growth.
- Other info: Collaborative team environment with opportunities for continuous improvement.
- Why this job: Make a real impact on product safety and quality in the healthcare sector.
- Qualifications: Degree in Engineering or Life Sciences and experience in quality management systems.
The predicted salary is between 29700 - 36300 £ per year.
Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.
Location: Durham
Contract: Full-time, temporary (12–14 months)
Working Hours: Shift work may be required (7am–3pm / 3pm–11pm)
About the Role
We are recruiting for a Quality & Regulatory Engineer to join a manufacturing business based in Durham, supporting quality assurance, product compliance and regulatory activities within a medical device manufacturing environment. This is an excellent opportunity for someone with experience in quality engineering, quality management systems or regulatory affairs who is looking to develop their expertise within a regulated manufacturing setting. You will play an important role in ensuring products meet the required quality, safety and regulatory standards, with a particular focus on medical device production and cleanroom operations.
Key Responsibilities
- Support the development, implementation and maintenance of quality control systems and procedures.
- Ensure products meet relevant quality, safety and regulatory requirements.
- Support regulatory affairs activities relating to medical devices.
- Assist with compliance against ISO 13485 and EU Medical Device Regulation (MDR) requirements.
- Prepare, review and maintain technical documentation and production procedures.
- Conduct product testing, inspections and evaluations to verify compliance with specified requirements.
- Investigate product non-conformances and manufacturing issues, identifying root causes and implementing corrective and preventive actions (CAPA).
- Collect and analyse quality data to identify trends and opportunities for improvement.
- Support internal and external quality audits.
- Provide guidance and training to production personnel on quality standards and procedures.
- Support medical device manufacturing activities, particularly within cleanroom environments.
- Work closely with production and quality teams to promote continuous improvement and maintain compliance.
About You
To be considered for this position, you will ideally have:
- A degree in Engineering, Life Sciences or a related discipline.
- At least one year of experience in medical device regulatory affairs or quality management systems.
- An understanding of quality assurance, quality control and regulatory compliance.
- Strong analytical and problem-solving skills, with the ability to investigate quality issues and identify corrective actions.
- Good attention to detail and the ability to maintain accurate technical documentation.
- Strong communication skills and the ability to work collaboratively with production and quality teams.
Quality & Regulatory Engineer in New Town employer: GPW Recruitment
Join a dynamic and forward-thinking engineering and manufacturing company in Lancashire, where innovation meets opportunity. As an Applications Engineer, you'll benefit from a collaborative work culture that prioritises employee growth and development, alongside competitive benefits that support your well-being. This role offers a chance to contribute to exciting projects while being part of a team that values creativity and excellence.
