Supplier Quality Engineer

Company: HCL America Inc
Location: Irvine
Posted on: November 22, 2022

Job Description:

Job Details :* Engineering, Technical, or Scientific discipline with 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, SAPJob Type: Full-timeBenefits:* 401(k)* 401(k) matching* Dental insurance* Employee assistance program* Health insurance* Life insurance* Paid time off* Relocation assistance* Retirement plan* Tuition reimbursement* Vision insuranceSchedule:* 8 hour shift* Monday to FridayWork Location: One location

Keywords: HCL America Inc, Irvine , Supplier Quality Engineer, Other , Irvine, California