Supplier Quality Engineer

Supplier Quality Engineer

7 Months

Colorado Springs Colorado 80921
This role will be 100% onsite. Job Description Summary
o Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio.
o Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requirement with R&D and design assurance against of part/product risk management file.
o Hands on driving and performing IQ, OQ, PQ and TMV at the suppliers.
o Strong Communicator to manage stakeholders and provide bi-weekly update to Senior Leadership management.
o Minimum of 20% travel in North America Job Description
Review and assess the OQ/PQ/IQ of suppliers, and support the supplier over TMV challenges.
Responsible for End to End assessment on Supplier Performance (NCRs, SQNs, SCARs, SICRs,)
Successfully integrates across multiple product lines and businesses
Thorough knowledge of the business areas supported including their strategies, goals, competitive environment, functional processes, and organizational dynamics
Fosters excellent cross-functional communications and integrates the work of managers to achieve business objectives.
Navigate within ambiguity and drive resolution within Quality Management System.
Strong Communicator, experienced in Statistical analysis, and power point presentation.
Minimum of 10 years of related engineering experience (medical device or regulated industry preferred).
Broad cross functional experience.
Advanced Quality Engineering and Continuous Improvement skills.
Direct working relationships with suppliers
Leadership exposure in a technical capacity
Project Management practice
Direct shop-floor production engineering sustaining experience