Quality & Regulatory Engineer

Quality & Regulatory Engineer

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

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Support the development, implementation and maintenance of quality control systems and procedures.

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Ensure products meet relevant quality, safety and regulatory requirements.

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Support regulatory affairs activities relating to medical devices.

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Assist with compliance against ISO 13485 and EU Medical Device Regulation (MDR) requirements.

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Prepare, review and maintain technical documentation and production procedures.

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Conduct product testing, inspections and evaluations to verify compliance with specified requirements.

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Investigate product non-conformances and manufacturing issues, identifying root causes and implementing corrective and preventive actions (CAPA).

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Collect and analyse quality data to identify trends and opportunities for improvement.

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Support internal and external quality audits.

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Provide guidance and training to production personnel on quality standards and procedures.

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Support medical device manufacturing activities, particularly within cleanroom environments.

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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:

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A degree in Engineering, Life Sciences or a related discipline.

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At least one year of experience in medical device regulatory affairs or quality management systems.

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An understanding of quality assurance, quality control and regulatory compliance.

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Strong analytical and problem-solving skills, with the ability to investigate quality issues and identify corrective actions.

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Good attention to detail and the ability to maintain accurate technical documentation.

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Strong communication skills and the ability to work collaboratively with production and quality teams.

Desirable experience:

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Knowledge of ISO 13485 quality management systems.

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Previous exposure to EU MDR compliance.

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Experience with technical documentation within a regulated manufacturing environment.

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Exposure to medical device production, cleanroom operations, product validation or quality auditing.

The Opportunity

This is a full-time temporary opportunity expected to last approximately 12–14 months, providing the opportunity to gain valuable experience within a regulated medical device manufacturing environment.

The successful candidate will work closely with the Quality Assurance Manager, supporting quality systems, regulatory compliance and production activities.

Apply Now

If you have a background in quality engineering, medical devices or regulatory affairs and are looking for your next opportunity, we would like to hear from you. Submit your CV today to be considered