Sr. Supplier Quality Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Supplier Quality Engineer for a 12 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Responsibilities related to sustainment: Ensure an un-interrupted supply of conforming components to Operations. Root cause analysis of part related manufacturing defects and warranty concerns. Manage supplier initiated changes; serve as the change owner in change management system. Update prints and generate Engineering Change requests. Update gage plans and attribute charts. Serve as a subject matter expert, for your assigned commodity; share expertise within global organization. Support manufacturing transfer projects. Support strategic sourcing projects Disposition material quarantined in MRB. Responsibilities related to development: Foster strong relationships with supplier-partners. Analyze non-conformance data to prioritize projects and to solve systemic supplier issues. Create and execute supplier development plans. Drive continuous improvement actions with suppliers to reduce part related defects. Evaluate and qualify of new suppliers, especially those with advanced technologies, to support product innovation. Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection. Make pro-active supplier site visits. Train/educate suppliers on Quality topics: Quality System, problem solving, validation, and lean. Push lessons learned from the supply base back to R&D for incorporation into next generation designs. .Provide support for all Supplier Quality related activities. Assist in Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.
Bachelor s degree required
Technical understanding of manufacturing prints and tolerencing
Strong communication skills
Strong problem solving skills
Strong team player
Good understanding and ability to work with Microsoft Office
Basic understanding of manufacturing processes
Fluent in written & oral English
Willing to travel in support of business needs to different geographical locations
Basic understanding of project management
Demonstrated interpersonal skills
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 suppliers
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 suppliers.
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
Support ECR process in local change control systems
Participate in supplier audit program planning, execution and closure
Participate in supplier reviews for assigned suppliers as required
Participate in cross functional projects both locally & globally as required
Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers