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Elekta Group operates a centralized category and business driven procurement function operating across four main direct material countries: situated in UK/Netherlands/Sweden/China, and 3 indirect regions Americas, Europe and China/APAC. The Procurement function is structured as a matrix organisation with centralized leadership for Direct Purchasing/ Indirect Purchasing/ Supplier Development & Quality, Process & Systems and the Local Management in each of the regions for direct and indirect material.
The requirement for Supplier Development and Quality activities varies with site and as such this role may report into a Supplier Development and Quality Manager or into the local Head of Procurement. The role of Head of Supplier Development and Quality will drive the global direction of the Supplier Quality and Development teams through the direct management position.
The purpose of the Supplier Development and Quality Engineer role is to be a specialist in the tools, processes and management of supplier quality and development processes. Indirectly managing and leading others, driving improvement initiatives spanning multiple areas of the organization and geographical locations.
Management of supplied material quality issues raised by the factory/installation/supplier and customers through NCR and CLM processes. Working with suppliers to ensure quality problems are effectively Contained and Root Cause analysis conducted using appropriate problem-solving tools, including 8D, 5-Whys, Fishbone and DOE. Ensure effective CAPA is implemented to prevent reoccurrence, including horizontal deployment across other product lines.
Develop proactive quality plans with suppliers and promote a zero-defect culture that reduces the need for upstream inspection and testing activities.
Develop positive relationships with internal and external interfaces, including suppliers, strategic buyers, category heads, procurement heads, R&D, manufacturing and service ensuring customer requirements are understood and achieved.
Plan, conduct and fully document part approvals on new and changed parts to ensure compliance to the drawing specification in accordance with Elekta agreed process. Where required, conduct physical part inspections, process audits and document checks at onsite and offsite locations.
Where appropriate, use Core Quality Tools (APQP, FMEA, MSA and PPAP) to proactively build quality into supplied product quality.
Knowledge of ISO13485, 9001, 14001 and their application to Elekta and Elekta supply chain.
Conduct approval, surveillance and capability audits of suppliers QMS, parts, processes and documentation to ensure compliance with relevant ISO13485, 9001 and Elekta’s Quality Agreement requirements (QAA), including the identification and escalation of quality and business risk. Writing of audit reports, audit non-conformances and opportunities for improvement. Follow up of actions at both supplier and internally at Elekta within agreed timescales.
Write, issue, negotiate and manage Quality Agreements with suppliers (QAA’s)
Provide quality management and manufacturing engineering support to category strategy and sourcing board initiated projects
Support internal, external, QMS and cross functional process improvement initiatives. Update Elekta QMS documentation as required.
Drive supplier development initiatives and A3 projects which will help meet procurements QCDIM targets and requirements. Train suppliers in best practice tools, processes and initiatives, including LEAN, Six Sigma, Value Stream mapping, Value Engineering, DFM, DFA, PFMEA, Process Validation and technical/manufacturing capability. Address, efficiency and output gaps where required.
Actively engage and participate in NPI, PCP and Elekta Programmes/Projects to promote DFM/DFA. Proactively drive quality into products through active participation in the Engineering change process, bridging suppliers, engineering and historical quality performance of parts to improve the quality of design. Raise Demand Management and Engineering change requests where required.
Use formal risk assessment tools to assess new manufacturing and supply chain processes and implement mitigation action plans as required to meet business objective and targets.
Support the selection and implementation of new suppliers according to the sourcing process and maintain the integrity of the approved supplier list and supplier data in relevant systems. Ensure supplier approval, supplier management and compliance documentation are maintained so we always remain audit-ready.
Provide manufacturing engineering expertise, supplier development and quality resource to support procurement cost down initiatives.
Support the management of suppliers QCDIM performance, including measurement tools and processes.
Manage supplier raised changes/escalations and deviation approvals (concessions) through to approval stage.
Complete QMS Training and QMS document reviews as required.