Overview
Quality Assurance Specialist Jobs in Nicosia, Nicosia, Cyprus at MammoCheck
Title: Quality Assurance Specialist
Company: MammoCheck
Location: Nicosia, Nicosia, Cyprus
About MammoCheck
MammoCheck Ltd is a Cyprus-based medical technology company and a Frederick University spin-out. We are developing an AI-powered Software as a Medical Device (SaMD) for adjunctive breast cancer screening. Our solution pairs consumer thermal imaging hardware with a proprietary deep learning model, delivered through a smartphone application, and is designed to support rather than replace clinical judgement. The product is positioned strictly as adjunctive and investigational while we advance toward FDA 510(k) clearance and CE marking under the EU Medical Device Regulation (EU MDR). We are now building the in-house regulatory and quality capability that will carry the product through clinical validation, regulatory submission, and market entry.
Role overview
As Quality Assurance Specialist, you will be responsible for implementing MammoCheck's quality management system to ISO 13485 and preparing the company for certification. This is genuine implementation ownership, not an assistant role. You will build the QMS processes, run document control and CAPA, and keep the company audit-ready, while receiving structured guidance and training from our external QMS consultants and hands-on support from the management team and the technical team. It is an exceptional opportunity for a motivated professional to implement a complete medical device quality system from the ground up, with expert mentorship built in.
What you will implement
- Implement the quality management system to ISO 13485, building the processes, procedures, and records with templates, training, and guidance from our external QMS consultants.
- Set up and run document control, change control, CAPA, and nonconformance handling across the organisation.
- Implement and maintain the risk management file in line with ISO 14971.
- Implement software lifecycle documentation and traceability in line with IEC 62304, working directly with the software and AI team.
- Prepare the company for internal audits, the ISO 13485 certification audit, and Notified Body assessments, including running mock audits with our consultants.
- Implement FDA quality readiness, including QMSR alignment and 21 CFR Part 11 considerations for electronic records.
- Operate and improve the internal compliance system used to manage quality records and workflows, with support from the technical team.
- Guidance, training, and support
- You will not be doing this alone. Strategy and specialist judgement are provided by our external consultants, who will train you on the frameworks, review your work, and remain available throughout. The management team provides direction and removes blockers, and the technical team supplies the engineering inputs and tooling you need. Your job is to implement, own the day-to-day system, and grow into the expert in the room.
Required qualifications
- A degree in life sciences, engineering, quality management, or a related field.
- One to three years of experience in quality, regulatory, or a documentation-heavy role, ideally in medical devices or another regulated sector.
- Familiarity with, or a strong willingness to learn, ISO 13485 and medical device quality requirements. Full training will be provided by our external consultants.
- Awareness of ISO 14971 and IEC 62304.
- A self-starter mindset. You will implement the system hands-on, with guidance rather than day-to-day supervision.
- Strong attention to detail, good documentation habits, and excellent English.
Preferred qualifications
- Exposure to Software as a Medical Device or software quality.
- Progress toward ISO 13485 auditor training or an ASQ certification.
- Familiarity with 21 CFR Part 11 and FDA quality requirements.
- Knowledge of Greek.
What we offer
- A competitive salary.
- Flexible and hybrid working arrangements.
- Structured guidance and training from our external regulatory and quality consultants and specialist FDA and EU MDR advisors.
- Direct support from the management team and the technical team, so you are never implementing alone.
- Support for professional development and certification, including RAPS and ISO 13485 training.
- Real implementation ownership from day one, with a clear path to grow into a senior quality role as the company scales toward certification and beyond.
