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.
Responsibilities: - 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.
Required Experience: - 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.
Helpful Experience: - 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.
Minimum Qualifications: - Bachelor's or Master's degree in a Life Science, Engineering, or related field.
Salary & Benefits: - 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.