Quality Systems Engineer

Cure Talent Ltd; East Hagbourne; On-site; GBP 40,000 - 60,000; Full time

Job summary

A medical device manufacturer in East Hagbourne is seeking a Quality System Engineer to own and manage quality processes within their Quality Management System. Responsibilities include compliance with ISO 13485 and MDR requirements, managing non-conformances and audit processes, and training staff on quality procedures. Candidates should have experience in a medical device Quality function, practical ISO 13485 training, and a relevant degree. This hands-on role offers an opportunity to drive continuous improvement in quality management.

Qualifications

• Experience working within a Quality function in the medical device industry.
• Practical experience and training in ISO 13485.
• Knowledge of MDR 2017/745 and FDA 21 CFR Part 820 is advantageous.

Responsibilities

• Manage and maintain the Quality Management System, ensuring ongoing compliance.
• Oversee document control and maintenance of controlled documentation.
• Manage non-conformances and supplier corrective actions.
• Coordinate customer complaint investigations and generate reports.
• Oversee audits and ensure actions are completed effectively.

Skills

Experience in Quality function in medical device industry

Practical training in ISO 13485

Strong organizational skills

Attention to detail

Cross-functional collaboration

Education

Degree in relevant discipline

Job description

Overview

Cure Talent are delighted to be partnered with a medical device manufacturer as they look to strengthen their Quality function. We have an exciting opportunity for a Quality System Engineer to join the team and take ownership of day-to-day quality processes within an established Quality Management System.

As the new Quality System Engineer, you will be responsible for managing and maintaining core quality processes, supporting compliance with ISO 13485 and MDR requirements, and driving continuous improvement across the business. Reporting into the Quality Director, this is a hands-on role with broad exposure across audits, complaints, non-conformances, and GMP activities.

Responsibilities

• Manage and maintain the Quality Management System, ensuring ongoing compliance with applicable standards.
• Oversee document control, including release, archiving, and maintenance of controlled documentation.
• Manage non-conformances, supplier corrective actions, and root cause investigations.
• Coordinate customer complaint investigations and generate technical reports as required.
• Oversee internal, external, and supplier audits, ensuring actions are assigned and completed effectively.
• Support deviation management and GMP review of manufacturing and quality records.
• Provide training and quality induction to ensure company-wide understanding of quality procedures.
• Support Management Review and Quality Improvement Review activities with data analysis and reporting.
• Act as deputy for PRRC responsibilities in the absence of the Quality Director.

Experience and Skills Required

• Experience working within a Quality function in the medical device industry.
• Practical experience and training in ISO 13485.
• Degree-qualified in a relevant discipline.
• Knowledge of MDR 2017/745 and FDA 21 CFR Part 820 is advantageous.
• Strong organisational skills, attention to detail, and ability to work cross-functionally.

If you're a Quality professional looking for a hands-on role focused on QMS ownership, compliance, and continuous improvement within a medical device environment, we'd love to hear from you.