Quality & Regulatory Engineer

GPW Recruitment; Houghton-le-Spring; On-site; GBP 42,000 - 54,000; Full time

Job summary

GPW Recruitment is seeking a Quality & Regulatory Engineer for a medical device manufacturing site in Durham. This is a full-time, temporary role (12-14 months) with potential shift work.

You will support QA, regulatory affairs, and production to ensure ISO 13485 and MDR compliance, manage technical documentation, conduct product testing and CAPA, and contribute to audits and training across teams.

Qualifications

• Degree in Engineering, Life Sciences or related discipline.
• At least 1 year in medical device regulatory affairs or quality management systems.
• Understanding of QA, QC and regulatory compliance.

Responsibilities

• Support development, implementation and maintenance of quality control systems and procedures.
• Ensure products meet quality, safety and regulatory requirements.
• Support regulatory affairs relating to medical devices.

Skills

Analytical thinking

Problem-solving

Attention to detail

Communication

Team collaboration

Education

Engineering or Life Sciences degree

Job description

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

• 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.

Desirable experience:

• Knowledge of ISO 13485 quality management systems.
• Previous exposure to EU MDR compliance.
• Experience with technical documentation within a regulated manufacturing environment.
• 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.