Supplier Quality Engineer with Medical Device

04 May 2024

Vacancy expired!

Description:·         Engineering, Technical, or Scientific discipline with minimum of 5-8 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated).·         Good Experience in IQ / OQ / PQ processes at Mfg sites·         Quality Engineering/Design or Process Excellence/Lean experience is preferred.·         Collaborate to complete Component Qualification, document evidence.·         Prepare Protocols, works requests & reports for Supplier Qualified components·         Collaborate with suppliers to collect evidence and/or develop Production Part Approval Process (PPAP)·         Knowledge of the QSR, Design Controls, and ISO quality requirements.·         Experience conducting Process / Design Failure Mode Effects and Analysis·         Understand and interpret all manufacturing audits, including ISO 13485 and other industry standards.·         Conduct supplier quality control audits on a regular basis to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards.·         Experience in CAPA execution and Non-Conformance management·         Very Good in Oral & Written Communication·         Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing)·         ASQ certifications are an asset·         Mechanical product knowledge is preferred. Problem-solving techniques including 8D, root cause analysis, and cause and effect analysis·         Knowledge in PLMs & ERPs like WindChill, ADAPTIV, AGILE, JDE, SAPRegards,Mohammed,PH - 229-264-4029. Text - (770) 852-8474).

  • ID: #49862034
  • State: California Irvine 92602 Irvine USA
  • City: Irvine
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2023-05-04
  • Deadline: 2023-07-03
  • Category: Et cetera