About CPI
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.
Hybrid Working
We’re embracing hybrid working to build a happier, more productive, and environmentally conscious workplace. Discover more about our new flexible working approach.
Why this role is important for CPI’s work
CPI has an exciting opportunity for a Quality Officer – Formulation and Photonics & Electronics to join our team. The focus of this role is to provide wide ranging support to the quality function, promoting and integrating quality into every aspect of our business. In this role, you will perform a variety of tasks in across areas of the quality system mainly focusing on the compliance to and maintenance of the CPI quality management system to meet ISO 9001 and ISO 13485 requirements in Formulation and Photonics & Electronics Technology Areas.
Projects within CPI encompass a broad range of process technologies and novel measurement and analytical techniques, and this is reflected in the diversity of customers and their expertise.
Key tasks
* Providing business administrative support for the maintenance and management of company digital/ electronic systems, for example, document and training management systems.
* Controlling and issuing manufacturing documents as and when required.
* Management of the QA Archive for ISO quality documents.
* Documenting and controlling activities for all controlled documentation including policies, SOPs and protocols.
* Participating in root cause analysis investigations arising from quality deviations, OOS and complaints as required.
* Supporting both internal and external audits including participation in audits, writing reports, agreeing CAPA and following these up as required.
* Logging and issuing of quality risk assessments, calibration, qualification and validation documentation as required.
* Assisting in the development, collating, reporting and escalation of trends and key quality metrics.
The person we are seeking
Essential:
* Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/ Engineering discipline plus significant industrial experience. Or
* Educated to Degree level (or equivalent) in a Scientific/ Engineering discipline plus relevant industrial experience.
* Quality system expertise and experience of operating within an ISO QMS environment, maintaining and monitoring quality systems compliant to ISO 9001 and ISO 13485.
* Strong attention to detail with a thorough approach and good organisational skills.
* Ability to work in fast paced environment, flexibility to adjust with moving priorities and ensuring attention to detail remains first class.
* Knowledge of ISO 9001 Business Management System.
* Knowledge of ISO 13485 Quality Management – Medical Device Compliance.
It would be great if you also had:
* Membership of a relevant professional body.
* Experience in the use and implementation of Electronic Document Management systems and QMS.
* Knowledge of key GMP Principles.
* Knowledge of ISO 14001 Environmental Management Systems Standard.
* Knowledge of FSSC 22000 Food Safety Systems.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees. This includes:
* Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
* Generous pension scheme
* Life assurance and accident insurance schemes
* Flexible working
* Learning and Development Opportunities
* Free parking
Additional Information
Please note this is a hybrid role with a minimum of 2 days per week on site at Sedgefield. CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.
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