To apply: Please email your CV and a covering letter outlining your interest in this position to firstname.lastname@example.org.
Want to be part of a team transforming healthcare?
We are looking for an experienced Quality Engineer to join us at an exciting time as we transfer our world-leading technology from R&D to manufacture. Our products will revolutionise healthcare options for millions and disrupt the Medical Imaging industry.
Medical imaging affects lives. An inconclusive first diagnosis can be frustrating and sometimes life threatening. A referral for a CT scan can mean a delay in diagnosis and therefore treatment. Moving a patient to and from an X-ray or CT machine in ICU or A&E can be dangerous and in radiology, early cancer detection is vital to help save lives.
We are helping make 3D imaging more accessible to the people who need it. We are producing a flat-panel X-ray source that is safer, lighter, more capable and lower cost than existing technology. We have developed and proved the technology and we are now preparing to bring our first generation of products to market.
Our manufacturing facility is located in Scotland’s central belt and our Operations team work closely with our R&D and commercial teams based in Oxford.
As our ideal candidate, you have a technical engineering background and experience in Quality Engineering roles within regulated product production environments. You have a minimum qualification of HND in Engineering, together with a recognised qualification in quality management (or equivalent experience).
You have practical knowledge and experience in a range of quality techniques, methods and tools and experience of conducting internal and external audits. You are skilled at building effective internal and external relationships. You are passionate about your work and about delivering quality objectives.
Main duties and responsibilities
• Leading Quality Control, including inspection of goods received, subassemblies and finished products
• Inspecting and testing materials, equipment, processes and products to meet quality specifications
• Investigating and troubleshooting product or production issues
• Developing corrective actions, solutions, and improvements
• Managing non-conformance including CAPA processes
• Collaborating with the Operations Manager to develop and implement controls and improvements
• Managing component stores
• Creating and monitoring supplier evaluation and audit programmes and schedules
• Attending supplier audits as a Quality Control representative for the company
• Full involvement in external and internal audits and risk assessments, taking corrective actions if needed
• Working with the Quality & Regulatory Manager to implement Product Quality practices and procedures compliant with relevant standards (including ISO13485:2016)
• Reporting KPI information to the Operations Manager
• Making recommendations to Quality Control processes and procedures to instil a culture of continual improvement across company and supplier sites
Essential skills and experience
• Knowledge and skills required to identify and document issues and the confidence to suggest and implement agreed process improvements
• Aptitude for analysis, organisation and planning
• Detail focus with the tenacity to see tasks through to their successful completion
• Ability to communicate effectively across teams and build strong internal and external relationships
• Comfortable working both independently and collaboratively within a team
• Familiarity with small electromechanical machines
• Familiarity with products requiring clean room assembly facilities
• Working in a highly regulated industry with a process-driven environment
• Working within a regulated product production industry (ISO9001 or ISO13485 preferred)
• Thorough understanding of Quality Management Systems (ideally within an ISO13485 environment)
• Experience of product CE Marking
Desirable skills and experience
• Working with MRP/ERP systems
• Lean six sigma qualification
• Root cause analysis
Further details and how to apply
This is a full-time (37.5 hours/week) position based primarily in Scotland’s central belt where we will be establishing our manufacturing facility. The role will also involve travel to work with our R&D and commercial teams at our Oxfordshire sites, as well as travel to our supplier sites. The role may initially include some time working temporarily from home while the production site is mobilised, or due to coronavirus restrictions. Compensation is competitive and commensurate with experience.
Please note that we are unable to provide sponsorship for visa applications for this role.
The closing date for applications is 20th September 2020, however should we find a suitable candidate before this date the position may be filled earlier.
If you feel that you would excel in this role we would be delighted to hear from you. Please email your CV and a covering letter outlining your interest in this position to email@example.com.