JOB SUMMARY
A key member of the technical team, focusing on improvement and implementation of the Quality Management System ensuring compliance with accreditation to ISO9001 and achievement of relevant standards including ISO 13485. Provide technical support for the projects and operations teams. Improvement of systems and processes will be key to ensure repeatability, traceability and scale up. Experience of working within a manufacturing environment essential.

TYPICAL JOB ACCOUNTABILITIES

• Maintain and further develop quality systems processes and policies
• Lead a Quality culture throughout the organisation based on right first-time principles
• Review and document all activities as necessary to enable 3rd party assessment/audit of work undertaken in compliance with the relevant Quality standards.
• Ensure Environmental and Health and Safety standards and procedures are adhered to.
• Facilitate the development and review of FMEA’s and Control Plans with Product Development, NPI and Production
• Lead internal auditor, capable of planning and executing internal and external audits and liaising with external accreditation bodies as the key point of contact
• Authorising the quarantine and containment of components and products
• Collate process parameters and liaise with the QC Technicians and operations staff to establish process trends.
• Identify and implement improvements in process performance and product quality monitoring.
• Ensure routine laboratory tasks are performed and documented including calibrations and maintenance.
• Ensure the provision of SPC analysis through the compilation of data and interpretation of results.
• Review the root cause analysis on any materials out of specification via the Corrective and preventive action (CAPA) system.
• Implement a robust change management system.
• Ensure regular management reviews of process performance and product quality
• Deliver appropriate training to the wider team ensuring understanding of quality metrics
• Identify opportunities for process improvements that can be readily scaled up.
• Working with the QC technicians and the technical team, make recommendations for improved material and process analysis, these should be supported by verifiable SOP’s.
• Working with the manufacturing team becoming conversant with and developing standard operating procedures and risk assessments as required.
• Knowledge of working with hazardous materials and understanding of process formulation.
• Attend appropriate training courses, seminars and conferences as may be required by the company.
• Prepare monthly reports based on KPI’s.
• Provide support for commercial and technical projects in line with business strategy.

• Undertake tasks in support of business growth and technology exploitation.

Qualifications:

• Degree educated (or equivalent) in Quality Management, science, or another relevant subject.
• Experience of working in a manufacturing and research and development environment in an appropriate related field.
• Experience of managing people within a manufacturing environment preferably safety critical products.
• Ability to understand and communicate complex technical issues and drive problem resolution
• Familiar with problem solving tools, root cause analysis, 5 Why, 5 S and able to analyse outcomes and trends.
• Experienced in creating and analysing outputs from inspection and reporting on their findings
• Advanced IT skills
• ISO9001 and ISO13485 experience and knowledge of systems and audit requirements.
• Knowledge of ISO14001 an advantage
• Internal and external Customer focus with right first-time approach.

Job Types: Full-time, Permanent

Salary: £40,000.00-£45,000.00 per year

Schedule:

• Monday to Friday