At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.
With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.
Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.
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 opportunity for an experienced Quality Manager to support the Electronics & Photonics business unit. We are looking for a candidate who holds experience working directly with customers in a regulated/certified environment – ideally ISO 13485.
CPI is on an evolutionary quality culture journey, moving from individual standard focused Quality Management Systems to a ‘one CPI’ QMS. This provides a unique opportunity to develop, shape and implement quality management systems across a diverse business, in compliance with multiple external standards, and to support the needs of a business operating from the R&D space to product manufacture.
To support the journey, we have invested in a new electronic QMS, which we will develop, build, validate and implement H1 next year. To complement the one CPI Quality Management System, we are undertaking an organisational and behaviour change journey to drive a quality culture shift, providing an opportunity to build upon the ‘softer’ side of quality.
Quality is a key foundation of our business and through effective quality management, CPI will continue to add value to the company and help achieve its business goals. 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 lead, develop and implement appropriate methodologies, practices and procedures that are consistent with industry standards within an operation comprising of both R&D and pilot production activities, focusing on the enhancement, sustainability and continuous improvement of the CPI Electronics and Photonics quality management system to meet ISO 13485 and ISO 9001 requirements.
Key responsibilities will include:
To be an effective associate of the CPI Quality function/team in terms of participation, delivery and implementation of Business and function goals – quality function initiatives – quality function policies/guidelines – quality function strategy
Support development, innovation, improvement and monitoring of the Quality Management System.
Support delivery of the CPI Audit programme:
Collaborate with the Business Unit Leadership team and all department heads to ensure compliance and quality assurance are a shared responsibility – measured against recognised and appropriate standards of control.
Provide quality support, guidance, and assistance for any business development opportunity as it relates to your BU.
Innovate and improve the Quality Management Systems. Support and where appropriate, lead, simplification of processes and systems to reduce Human Error and the Cost of Poor Quality.
Identify and escalation of all compliance issues with the potential to cause significant quality impact, business impact or audit non-conformance within the Business Unit. Support the development and execution of remediation plans.
Key Responsibilities – Business Unit: -
Ensure that the quality management system (QMS) satisfies the requirements for the different ISO certifications held by the business unit (including ISO13485 relating to the manufacture of medical devices) and achieve re-certification against those standards as required.
Lead investigations into quality incidents raised where they relate to some aspect of work carried out within the business unit.
Identify, implement and manage quality systems and specific controls, to meet the changing needs of the Electronics and Photonics customers and clients.
Provide quality expertise and support for CPI projects where customer interaction for quality issues is required.
Establish processes to drive continuous improvement in relation to CPI Quality systems and controls
Develop a culture of quality within the organisation, through effective training, coaching and influencing of CPI employees at all levels across all business platforms.
Candidate Dependent Responsibilities – ISO 13485* / *MDR* Regulatory Requirements: -*
Advise, inform and perform regulatory compliance activities relating to medical devices
The person we are seeking
Will ideally be educated to a degree level (or equivalent) in a Scientific/Engineering discipline plus hold relevant industrial experience.
It is desirable that you hold a qualification in a quality discipline or membership of a recognised quality group or committee.
Will have relevant experience in QMS development/enhancement/improvement and implementation of new systems.
With demonstrable experience hosting compliance inspections and customer audits. Experience performing audits is essential, ideally at a qualified lead auditor level.
Will have previous experience in Quality Risk Management
What does CPI* offer you?*
At CPI, we offer a wide range of benefits to our employees, this includes:
Find out more about our culture and benefits.
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.
Job Types: Full-time, Permanent
Salary: £45,000.00-£57,000.00 per year
Work Location: Multiple Locations