We are looking for a Quality Assurance Consultant with a technical and quality management system standards relating to device design and development background to join one of the UK's leading product design consultancies. You will be involved in a wide range of new product R&D projects from design to manufacture, applying your regulatory knowledge to device development. As a Quality Assurance Consultant, you would be supporting a diverse spread of design and development activities, responsible for ensuring compliance to relevant international standards and regulations.
- General QA support
- Supporting the QA Manager and Head of QA to undertake responsibilities core to QA such as:
Offering quality and regulatory support across a diverse range of projects requiring compliance to product and technical standards in addition to ISO 9001, ISO 13485 and FDA's QSR.
Liaising with project managers at the start of projects to ensure good alignment with our internal processes and external regulatory requirements, and that quality documentation is complete and appropriate.
Maintaining up-to-date knowledge and understanding of applicable global (typically EU and US) regulations and appropriate international standards.
Providing QA-related advice to project-based colleagues, offering clear and pragmatic solutions across a diverse spread of projects.
Updating company procedures and processes as required, and ensuring significant changes are appropriately communicated around the business.
Undertaking system and project compliance audits.
- Process improvement initiatives:
Working alongside colleagues in QA or the wider business, you will
Play a key role in the internal development and improvement of our core processes, covering project management, medical device development, non-medical product development, risk management and software development.
Maintain awareness of potential changes to international standards and regulations. Where changes arise, you will need to understand the size and scale of impact to the business, to plan our approach, and to manage activities to ensure compliance.
Manage specific QA responsibilities to enhance company and division-wide activities.
Evolve QA processes, by identifying and/or implementing opportunities for improvement.
A degree in engineering or the life sciences.
A good understanding of the international requirements to ensure compliance with quality management system standards, such as ISO 9001 and ISO 13485. This experience may have been gained in a QA or regulatory position, or in a related, highly associated role.
The ability to think creatively, select optimal approaches, encourage change and effectively implement solutions.
The ability to work independently and show leadership in managing, undertaking and communicating activities.
The ability to take ownership of initiatives, deliver results, and strive for continuous improvement is key.