Quality Specialist

CPI are looking to appoint a Quality Specialist to provide wide ranging support to the quality function, promoting and integrating quality into every aspect of our business.

In this role, the Quality Specialist will perform a variety of tasks in support of specific areas of the quality system mainly focusing on the implementation, sustainability and continued improvement of the CPI HealthTech (HT) quality management system to meet ISO 13485 Product Development requirements.

Key tasks in the Quality Specialist role will include (but are not limited to the below), please download the job description for full details available on the CPI careers page:

• Embrace and role model the desired behaviours to exemplify our Company values, promoting an ethical, positive company culture.


• To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), ISO 13485 (Product Development), Data Integrity (DI), quality and best practice requirements.


• Closely working with HT Regulatory and the HT Operations teams to develop and implement the Quality Management System to deliver Integrated Product Development compliant with ISO 13485 requirements, ISO14971 and associated regulatory requirements.


• Lead, advise and guide on design quality matters relating to ISO 13485 Medical Device Product Development activities.


Lead product risk management activities, as well as design control processes.

• Participation in the supplier assessment program including audits, supplier evaluation and technical quality agreements.


Author, review and approval of documentation including policies, SOPs and protocols.


• 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.


• Possesses significant quality system expertise and experience of operating within an ISO 13485 Product Development environment, developing, implementing and monitoring quality system including processes for design quality assurance purpose.


• Knowledge and experience in active medical devices, especially with associated requirements relating to IEC/EN60601 series.


• Exhibits professional mastery of principles and practices in ISO 13485 Product Design and Development processes, experience in NPD, risk management ISO14971, and design controls, gained in industrial environments.


It would be great if you also had:

• Chartered status with a relevant professional institution.


• Knowledge of ISO 9001 Quality Management System Standards.


• Experience in the implementation of electronic/digital systems for operational activities.


• Experience in IEC/EN62304.
  
  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., 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.

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


Find out more about our culture and benefits.