Graduate Software Quality Engineer – Design Controls Focus

About BlueBridge Technologies

BlueBridge Technologies (BBT) is a leading digital health technology company at the forefront of connected health and regulatory excellence. Our mission is to improve lives by developing pioneering technologies in therapeutic, diagnostic, and clinical research areas such as: cancer therapy; diabetes management; genetic testing; and clinical-grade wearables. We're a people-first company that values collaboration, innovation, and technical excellence in a fast-paced, purpose-driven environment.

The Role

We're looking for a passionate and ambitious Graduate Software Quality Assurance specialist to join our growing team. This is an excellent opportunity for a recent graduate to gain hands-on experience in a dynamic, high-impact environment where software meets medical innovation. You will work under the guidance of experienced professionals, contributing to the design, development, and documentation of software that complies with global medical device regulations.

This role has a strong focus on Design Control
— a critical component of the development lifecycle for Medical Software (including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)). You will help ensure our projects meet internal quality standards and external regulatory requirements, and you'll gain valuable exposure to international standards such as ISO 13485, IEC 62304, and FDA guidance.

What You'll Be Doing

- Assist in the creation, review, and maintenance of Design History Files (DHF) / Technical Files, including software development plans, requirements specifications, verification plans, maintenance plans, and testing records.
- Participate in risk management activities and design reviews.
- Collaborate with a range of stakeholders including engineers, human factors specialists, and quality professionals to ensure projects meet regulatory and quality requirements.
- Document and support the testing and validation of software at unit, integration, and system levels.
- Learn how to navigate international standards and regulations, including:

- ISO 13485 (Quality Management for Medical Devices)

- IEC 62304 (Software Life Cycle)

- ISO 14971 (Risk Management)

- US Quality Management System Regulations (21 CFR Part 820)

- Medical Devices Regulation (EU) 2017/745

- Help with the organisation and tracking of change control, configuration management, and non-conformance documentation.
- Help with the maintenance of the organisation's Quality Management System.

- Support internal and external audits and inspections.

What We're Looking For

Essential

- A recent Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related discipline.
- A strong interest in healthcare, software quality, and regulated industries.
- Basic knowledge of software development and testing principles.
- A desire to grow and learn about regulatory frameworks and best practices in medical device software development.
- Good organisational skills and attention to detail.
- Strong written and verbal communication skills.
- A valid work permit is essential.

Desirable

- Understanding of the software development lifecycle (SDLC) and software quality assurance principles.

- Familiarity with software development, and software testing methods or tools.
- Knowledge of Agile methodologies.
- Coursework or project work related to healthcare, medical devices, or regulatory compliance.

Why Join BBT?

- Work with cutting-edge technology that makes a real impact on patients' lives.
- Learn from experienced engineers and quality professionals.
- Gain early exposure to regulated industries and international standards.
- Collaborative, inclusive culture that supports your development.
- Hybrid work model with opportunities for professional growth.

- Opportunity to work across a variety of projects and devices.
- Competitive reward package including healthcare and pension.

Physical & Travel Requirements

- Minimal travel (

Working at BlueBridge Technologies

We're proud to be a people-first company. At BBT, you'll find a respectful, inclusive, and forward-thinking culture where your work has real impact. We support each other to grow, challenge assumptions, and push the boundaries of what's possible in digital health.

As an equal opportunity employer, we welcome applicants from all backgrounds. If you require reasonable accommodations as part of the recruitment process, please let us know.

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