Quality Systems Engineer Regulatory and Quality · Belfast · - #1716336

Location: Belfast, Northern Ireland (Hybrid)

Reporting to: Head of Quality

We are expanding our team and are recruiting a Quality Systems Engineer. In this role, you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for maintaining the quality system to ISO 13485 standards and associated product certification.

• Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management System, including document control, training management, and change management.


• Draft and update procedures, work instructions, and quality documentation.


• Collaborate with Engineering (Software and Hardware) and Customer Support teams to investigate and identify root causes of quality issues from customer complaints, internal non-conformances, and audit findings.


• Assist with implementing CAPAs and closing non-conformances.


• Work with cross-functional teams on documentation, risk management, and validation activities.


• Support quality compliance for SaMD products, including lifecycle and version control.


• Participate in internal and external audits.


• Analyze quality data and contribute to process improvements.

• At least 2 years of experience in a Quality role within the medical device industry.


• Hands-on knowledge of ISO 13485 and 21 CFR 820.


• Strong attention to detail and problem-solving skills.


• Ability to work effectively in a multidisciplinary, fast-paced, diverse team.


• Ability to work independently and prioritize tasks.


• Excellent communication, interpersonal, organizational, and IT skills.

• Experience with electronic Quality Management Systems (eQMS).


• Internal auditor qualification.


• Exposure to software as a medical device / IEC 62304.


• Technical or procedural writing experience.


• Familiarity with medical device regulatory requirements in the UK, EU, or US.


• Experience in electronics-related medical device manufacturing is advantageous.

• Bachelor's or Master's degree in a Life Science, Engineering, or related field.

• Competitive salary and performance-based bonus scheme.


• 25 days paid holidays.


• Benefits including pension match and private medical insurance.


• Opportunity to work with a motivated team on innovative technology impacting lives.

Note: We are not a licensed Visa sponsor and can only consider applicants who meet UK Visa right-to-work conditions.