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 the maintenance of the quality system to ISO 13485 standards and associated product certification.

As a Quality Systems Engineer, you will: 

• Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management System with activities including document control, training management and change management.
• Draft and update procedures, work instructions, and quality documentation.
• Collaborate closely with Engineering (Software and Hardware) and Customer Support teams to investigate and identify root causes of quality-related issues from customer complaints, internal non-conformances and audit findings.
• Assist with the implementation of CAPAs and closure of non-conformances.
• Collaborate with cross-functional teams on documentation creation, risk management, and validation activities.
• Support quality compliance for SaMD products, including lifecycle and version control.
• Participate in internal and external audits.
• Analyse quality data and contribute to process improvement initiatives.

Required experience:

• 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 as part of a multi-disciplinary, fast-paced diverse team
• Ability to work independently and prioritise tasks
• Excellent communication, interpersonal, organisational and IT skills

Helpful experience:

• Experience with electronic Quality Management Systems (eQMS)
• Internal auditor qualification
• Exposure to software as a medical device / IEC 62304
• Technical/procedural writing experience
• Familiarity with medical device regulatory requirements in the UK, EU, or US
• Experience in an electronics-related medical device manufacturing environment would be advantageous

Minimum Qualifications:

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

Salary & Benefits:

• Competitive salary and performance-based bonus scheme
• 25 days paid holidays 
• Competitive benefits including pension match and private medical insurance 
• Work with an awesome team of smart and motivated people on cool and unique technology that can positively impact the lives of millions of people

Please note:

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