Are you looking for a career in quality assurance, having gained experience of technical and quality management system standards relating to device design and development?
Do you understand the need to balance freedom to innovate on the one hand, with rigour in the design process on the other?
Cambridge Consultants provides stimulating surroundings where leading edge technologies and innovations challenge traditional approaches, so quality management must be flexible and inventive, but still ensure regulatory compliance.
Come and use your resourcefulness to contribute to projects with widely varying breadth of disciplines, scale, complexity and requirements.
The Quality Assurance (QA) Consultant will work within the corporate QA framework, taking responsibility for day-to-day activities within the QA group as well as management of a range of process improvement tasks as they arise. The role will involve supporting our diverse spread of design and development activities in the UK and US.
The QA Group is responsible for maintaining company management systems that support our business processes, and which comply with regulatory requirements and our clients’ expectations. The group maintains company registrations to ISO 9001 and ISO 13485 for both the UK and US sites. The group acts as the quality assurance interface with clients as required, and becomes directly involved in project work where applicable.
This is an excellent opportunity for an experienced quality practitioner with the ambition and ability to achieve results in a highly demanding industry and to find novel solutions to new and existing problems under tough commercial, technical, time, and sometimes regulatory, constraints.
The role encompasses day-to-day QA responsibilities and involvement in longer term process improvement initiatives, both within QA and across the business.
As QA Consultant, your specific responsibilities will include:
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 Cambridge Consultants’ 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
To meet the requirements of this role you should demonstrate 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.
You are likely to have a degree in engineering or the life sciences. In either case a key ability will be the skill and experience to interpret regulatory and standard requirements to ensure the downstream implications for our processes are clear.
With the skills and ability to undertake process improvement initiatives, you will be able to think creatively, select optimal approaches, encourage change and effectively implement solutions.
You will need to be a clear thinker, who can 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.
Why Cambridge Consultants?
Cambridge Consultants creates exciting and novel breakthroughs in technology and products. We help our clients achieve the kind of game-changing leap forward that will transform their whole business.
At the heart of what we do are talented and motivated multi-disciplinary teams empowered to create cutting edge technologies and systems to solve difficult problems for our clients.
We recognise and celebrate individual talent and we understand the importance of letting individuals be just that. Our people are here to do the best work of their lives and our job is to provide the platform for them to do it. That means letting people pursue the projects that interest them and develop their career in whatever direction they choose.