Quality Career Function

Typical job titles within this function include:

• Quality Systems Engineer
• Quality Engineer
• Supplier Quality Engineer

The role profile below gives an insight into a typical opportunity within our Quality team.

Quality Systems Engineer

Overview of the Opportunity:

The Quality Systems Engineer (QAE) will be responsible for the maintenance of quality policies, processes and documentation – providing quality system direction, guidance and training for the company’s Quality Management System. The QAE reporting to the Global Head of Quality, also has the critical responsibility for ensuring compliancy with the evolving requirements of ISO 9001 and other essential quality accreditations. They will also work closely with the project team to migrate to an Integrated Management System.

About the Role:

• Guiding the business and process owners through any non-conformities that should arise from ISO 9001:2015 audits
• Maintaining and driving the UK Technical Centre’s compliance to the ISO 9001 certification by developing and managing the internal audit schedule
• Manage QMS structure and content to adhere to ISO 9001 and associated quality standards
• Perform ISO 9001 internal audits and coach newly trained auditors
• Manage customer and third-party audits (approximately 25 per year)
• Facilitate resolution of any non-conformities raised from external audits
• Perform QMS introduction training as part of the company on-boarding process for new employees
• Promote the continuous improvement of systems and processes throughout the company
• Understanding and acting as the voice of the customer (VOC) and make effective decisions on quality issues on behalf of the customer
• Contribute to the ongoing development of internal systems and procedures to improve product quality and reduce quality costs within the company
• Maintaining close contact with production from the quality function and strong awareness of internal process concerns and corrective actions
• Provide meaningful feedback and reports on audits and test results to ensure non-conformance can be captured and relevant recommendations made

About your Talent:

• Experience of ISO 9001:2015
• ISO 9001 Lead Auditor
• Proven experience of testing or working with electronic, electronical, mechanical or software products
• Experience of developing and maintaining quality system processes
• Demonstrable experience of training delivery to diverse audiences
• Proven track record of working with IT E-Systems is essential
• Competent in following established business policies and procedures and influencing stakeholders to follow process
• Coordinate, execution, monitoring and maintenance of quality processes where designated
• Identify opportunities of improvement within the Quality System process
• Perform detailed quality review and approval of all quality documents
• Offers commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies
• Strong technical ability across MS suite and ability to learn new technology quickly and comprehensively
• CQI or IQA L3 or above
• ONC/BTEC Diploma (or equivalent) in Manufacturing/Engineering
• Experience of working within or introducing an integrated management system would be hugely beneficial
• It would be desirable for the suitable candidate to have experience of working in the medical device industry or / and understanding of ISO 13485