Receiving Inspection Remediation Engineer/Process Quality Engineer II

Usdm Life Sciences Bothell , WA 98021

Posted 1 week ago

Receiving Inspection Remediation Engineer (Process Quality Engineer PQE)

Description: 1. Minimum 10 - 15 years professional experience in the applicable role of Procurement Engineering, Manufacturing or Material Engineering 2.

Experience interacting with BOM suppliers on the following types of parts or products: mechanical, electrical, electro mechanical 3. Experience reading blueprints/specifications and determining CTQ characteristics. 4. Experience/understanding of general requirements for the incoming inspection of components, supplies, finished goods. 5.

Experience specifying certificate of analysis/conformance requirements. 6. Experience Test Method Validation (TMV) and Measurement System Analysis (MSA). 7. Working knowledge of the QMS (21CFR820) preferred 8.

Project Management or strong coordination skills preferred. 9. High energy, articulate, and works with a sense of urgency required

Education: Bachelor / Master engineering degree or equivalent. Expert and technical lead with proven experience.


Location: Must be able to be on site full time in Bothell, WA.

Responsibilities:
1.

Update the purchasing spec with compliance to the requirement from Central Remediation Team 2. Coordinate with TPE team to complete the DFM review / alignment with external suppliers 3. Initiate EC relevant to the change of the purchase parts 4.

Strong support to Central Remediation Team for relevant EC actions 5. Identify and document appropriate methodology to assess conformance of a component to specifications 6. Complete the FAI report 7.

Support SQE team to communicate with external suppliers in technical perspective to complete the CoC, CoA 8. Ensure the SCN (Specification Change Notification) implementation/handshake in/with supplier.

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Receiving Inspection Remediation Engineer/Process Quality Engineer II

Usdm Life Sciences