Supplier Quality Engineer - TechDigital
Irvine, CA
About the Job
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, SAP
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, SAP
Source : TechDigital