|Salary: £35000 - £45000 per annum
|Sector: Medical Devices
|Contact: Matt Henocq
Supplier Development and Quality Engineer
The purpose of this role is to manage the quality of parts bought by my client They source electrical and mechanical parts from suppliers globally, you will work with them to assure the quality meets our standards throughout the product life-cycle.
This will mean working with engineers: at suppliers; in the field; in our factories & at our design centre.
You'll need to quickly understand technical engineering problems & work with others to implement robust solutions.
- 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, 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 company agreed process.
- Where required, conduct physical part inspections, process audits and document check at onsite and offsite locations.
- Where appropriate, use core quality tools (APQP, FMEA, MSA and PPAP) to proactively build quality into supplied product quality.
- The role requires a working knowledge of ISO13485, 9001, 14001
- 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 of audit reports, audit non-conformances and opportunities for improvement. Follow up of actions at both supplier within agreed timescales.
- 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 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.
- 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.
- 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.
What you bring
- A Bachelor graduation or above within engineering.
- 3 years of work experience relating to quality management, quality assurance & process control is preferred.
- Familiar with factories & manufacturing process
- You must have quality audit experience & ideally be lead auditor certified to ISO 9001 or ISO13485. Certification to lead auditor ISO13485 is required & will be provided by my client if required.
- Good English skills written and oral.
- Well-developed analytical abilities, system problem-solving and quality improvement skills.
- Good coordination and communication skills.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.