INCOMING QUALITY ENGINEER I

Job Overview

Core responsibility of the Incoming Quality Engineer is to ensure Quality on purchase components, as part of the Global Supplier Quality function supporting Manufacturing plants, by implementing a robust containment action in the entire supply chain and initiating escalation if applicable, using his / her knowledge on problem solving methodologies and technical expertise on the specific material categories (i.e., resins, tubing, medical device components, etc.) working in close collaboration with suppliers, the Global SQ counterparts, TE plant quality, and other internal functional stakeholders.  

Tasks Summary & Responsibilities

•    Understand TE Production processes and confirms if supplier’s components are outside specifications.
•    Create / Maintain Incoming Quality Inspection Plans (QIP) in the system in collaboration with ASQ (PPAP) / SQE (Sustaining & Complaints) supported by IQI.
•    May support New Product (NPD) ramp up on production lines, trial runs with supplier components and other activities, upon request.
•    Perform Approved Supplier List (ASL) Management activities per assigned TE Medical site / Supplier responsibility.
•    Perform Supplier Change Management activities in conjunction with SQE per assigned TE Medical site responsibility.
•    Support Supplier Audit activities in support of SQE / Lead Auditor as needed.
•    Support SQE during the Chargeback process.
•    Acts as Liaison person between Suppliers and TE SQ internal Customers, as needed. 
•    Participates on the Supplier Performance Monitoring and Reporting process (i.e., provide data within response time)
•    Owner of Containment activities in collaboration with IQI (block stock, initiate sorting activities internal or external, etc.) following the local Non-Conforming (NC) material procedures for Supplier products.
•    Initiate and follows up incoming NC material disposition, containment, sorting, or rework requests to Suppliers until resolution.
•   Owner of NC process for supplier responsible non-conformances, including containment, disposition, investigation, and closure.
•   Owner of Complaint Handling / Problem Solving for external Supplier’s responsible incidents from all sources (i.e., internal and external customers, Production, Interplant, Incoming Inspection, etc.) after the safe launch period.
•   Perform SCAR Initial Assessments for supplier responsible claims, including review of QIP suitability. Issue, follow, and complete Notification and Correction SCARs with suppliers. Support SQE as needed for Full SCARs.
•   Track SCAR timelines via Global SCAR Tracking Log. Coordinate with SQE and complete extensions if needed.
•   Involves SQE for SCAR reviews / permanent problem solving & lessons learned initiation and follow up.
•   Communicate the SCAR progress to Plant Management until closure.
•   Responsible to clear Quarantined material due to a Supplier NC (justified complaint).
•   Perform other Supplier Quality tasks as requested by manager.
   

What your background should look like:

B.S. degree in Electrical/Mechanical/Industrial Engineering, or related field

Requirements:

•     At least 4 years of experience within Medical industry
•     Lean Manufacturing and Problem-Solving tools expertise
•     Incoming inspection Process and robust containment actions
•    Handling of non-conforming material
•    Demonstrated skills in driving actions for containing quality escapes, coordinating suppliers, Third party companies, and production internal quality and materials teams
•    Working knowledge on the specific manufacturing processes (Supplier and Internal).
•    Ability to work with a multifunctional team.
•    Thorough knowledge of Problem-Solving tools (8D at the minimum)
•    High sense of urgency.
•    Knowledge using process improvement techniques and methodologies (e.g., Kaizen, Lean) and tools (e.g., 8D, SPC, Capability Analysis, MSA, and FMEA, CP, PPAP, Safe Launch, CSL).
•    Software, MS Office: Word, Excel; Power Point. 
•    Basic knowledge in statistical software such as Minitab
•    Basic Knowledge in GD&T to read technical drawings
•    Problem solving skills
•    Assertive communication 
•    Experience handling measurement equipment, and performing measurements
•    Knowledge on ISO 13485 (preferred) / ISO 9001 (accepted)
•   Job requires minimum traveling
•   English fluent in written and verbal
   

Competencies