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Supplier Quality Engineer

Job in Irvine, Orange County, California, 92713, USA

Listing for: TechDigital Group

Full Time position
Listed on 2026-01-03

Job specializations:

Engineering
Quality Engineering, Process Engineer
Quality Assurance - QA/QC
Quality Engineering

Salary/Wage Range or Industry Benchmark: 80000 - 110000 USD Yearly USD 80000.00 110000.00 YEAR

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.

Responsibilities include:

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 Wind Chill, ADAPTIV, AGILE, JDE, SAP.

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