SUPPLIER QUALITY ENGINEER
Are you a Quality, Mechancial or BiomedicalEngineer interested in an opportunity that can offer you an exciting career in Supplier Quality.
Do you have excellent communication skills and enjoy travelling?
Then this is a great role for you!
+Working in partnership with the Global Supplier Network, you''''''''llbe involved in the ongoing support for the internal business units
+You will work with internal customers and suppliers in support of supplier quality issues;
+You will have ownership for supplier quality performance and measurement including KPI’s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
+Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
+Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suplliers
+Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
+Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
+Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
+Participate in 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
+Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier
+Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned supplier
+Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
+Deliver continuous improvement activities focusing on supplier quality
+Participate as required in SCRB in conjunction with key stakeholders
Professional Requirements- Required:
+Bachelor’s Degree in Engineering/Science fields or equivalent experience in a related industry
+Minimum of 1 year experience in manufacturing environment or equivalent
+Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
+Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
+Demonstrated working knowledge to positively influence supplier quality performance
+Analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
+Ability to plan, organize and implement multiple concurrent tasks
+Strong communication/ influencing skills. Must demonstrate the ability to effectively 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.
+Good knowledge of continuous improvement methodologies