Gold Group Limited
Location
Crawley, West Sussex | United Kingdom
Job description
Sector: Medical Devices Type: Permanent
Contact: Matt Henocq Job Published: 4 days ago
Supplier Development Qulaity Engineer
Responsibilities
Problem Management
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.
Change Control
Plan conduct and fully document part approvals on new and changed parts to ensure compliance to the drawing specification by client agreed process.
Provide quality management and manufacturing engineering support to category strategy and sourcing board-initiated projects.
Actively engage and participate in NPI and 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 & concessions where required.
Supplier Quality Assurance
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, R&D,
Where appropriate, use core quality tools (APQP, FMEA, MSA and PPAP) to proactively build quality into supplied product quality.
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.
Auditing
The role requires a working knowledge of ISO13485, 9001, 14001 and their application to clients supply chain.
Where required, conduct physical part inspections, process audits and document checks at onsite and offsite locations.
Conduct approval, surveillance and capability audits of supplier's QMS, parts, processes and documentation to ensure compliance with relevant ISO13485, 9001 and Quality Assurance Agreement requirements (QAA), including the identification and escalation of quality and business risk.
Writing audit reports, audit non-conformances and opportunities for improvement. Follow up on actions at both suppliers and internally at Elekta within agreed timescales.
Improvements
Support internal, external, QMS and cross-functional process improvement initiatives. Update 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 capabilities. Address, efficiency, and output gaps where required.
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 the approval stage and complete QMS Training and QMS document reviews as required.
Required skills and experience:
Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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Quality Assurance AssociateDescription:Responsible for supporting process owners in implementing processes and system changes. Supports my clients processes by performing specific project related tasks, reviewing documentation and materials or collecting, collating, ...
By submitting your details you agree to our T&C's
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