This inspiring company have developed a unique diagnostic device which aims to save 100,000 lives which could be lost to cancer and other diseases. This is a genuine opportunity to contribute to making a real difference to lives and play an important role within a very special organisation.
The company are based in a fantastic location on Cambridge's Science Park. Operating a hybrid working model with 2/3 days in the office each week, they are a collaborative team who enjoy each other's company and gain great satisfaction for working towards such a worthy cause.
Reporting to the Interim QA Manager, you will lead and manage a small team and ensure that QA issues are dealt with in line with the company QMS, International Standards and customer requirements. It will also be your job to help implement and drive a culture of quality throughout the business and support the evolvement of the QMS as needs change.
The person we are looking for should have experience leading a QA team supporting a QMS currently conforming to ISO 9001:2015 certification. Any knowledge of MDD 93/42/EEC, MDR 2017/745, FDA, ISO13485, 21 CFR 820 is highly desirable. You should be trained in a suitable selection of Quality Tools: Internal/External/Customer Audits, Risk Analysis, RCA etc and have experience of digital document management systems, such as CogniDox, Q-Pulse or similar. You should also have experience of using electronic approvals process for sign-off of documents. Excellent use of Excel is essential.
You're likely to have a Quality related CPD log showing your formal training and development activities related to ISO standards and European Directives.
You should be a hands-on, inspirational manager; someone who enjoys the practical part of the work but can also step up and lead your team. You will need to be a confident communicator; someone who is able to direct, empower and guide. You will also influence and engage (and sometimes challenge) other internal teams, so effective relationship building skills are necessary.
For the successful individual who joins this team, you will be part of a relaxed, friendly, flexible and international working environment with a lively team-spirit. There is a share options scheme and private medical insurance and other generous benefits.