Sr. Supplier Quality Engineer
Texas, Dallas-Fort Worth-Arlingt
Our client, a Global Medical Device Manufacture has an immediate opening for a Supplier Quality Engineer for a 6 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)
Provide support for all Supplier Quality related activities. Assist in Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.
Technical understanding of manufacturing prints and tolerancing
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
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.
Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable.
Good communication skills.
Willing to travel in support of business needs to different geographical locations.
Good knowledge of continuous improvement methodologies
Preferred industries are medical device, aviation, aerospace, automotive and defense
Must enjoy working in team environment
Must demonstrate good collaboration and communication skills.
Highly motivated and able to build relationships internally and externally.
Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction
Bachelors Degree required.