Supplier Quality Engineer

Harmonics Recruitment

Clare, Limerick

A Supplier Quality Engineer position has arisen with our client, a worldwide leader in the medical device industry. This is a permanent position offering the opportunity to join an established team, with an excellent salary and benefits package. Position Summary Working in partnership with the Global Supplier Network, you`ll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective. Key Areas of Responsibility Identify and plan training to address gaps in both skills and behaviour. Form input to performance reviews. Act as liaison for customer groups on key compliance issues. Act as Single Point of Contact for Strategic Suppliers in a Global function. Provides leadership to the SQE Team being responsible for the plant metric reporting and local SME for SQ procedures & processes. Ownership and reporting on all quality issues associated with suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated. Oversight of the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products. Act as a point of Contact for supplier Quality during External Audits and Internal Audits as required. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc.) Develop structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier. Liaising with the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues. Track supplier quality performance measurement (KPI’s) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review. Oversight of the Approved Supplier List (ASL) in conjunction with the Procurement function. Education an d Experience: Bachelor’s Degree in Engineering or Science fields. Minimum of 7 years’ experience in manufacturing environment. Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards. Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment. Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality. Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics. Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions. Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization. Demonstrated ability to work in cross-functional team environments. Willing to travel in support of business needs to different geographical locations. Percent Travel Required: Up to 40% For more information on this position or any other technical position please contact Melissa Foley on 061 336 136. This job originally appeared on RecruitIreland.com.

2467 days ago