Quality Engineer - Intellectt INC

Job Title: Quality Engineer Automation

Location: Irvine-CA

Position Summary:
Seeking a Quality Engineer to enhance product and process quality with a focus on CAPA, Root Cause Analysis, and NCR in a regulated manufacturing environment, specifically automotive and medical devices.

Key Responsibilities:

• CAPA: Lead and manage CAPA processes to address quality issues, ensuring corrective actions are implemented and effective.
• Root Cause Analysis: Perform root cause investigations using 5-Whys, FMEA, and similar methods; collaborate with teams to resolve recurring issues.
• NCR: Oversee NCR processes, documenting non-conformance issues, facilitating resolutions, and implementing corrective measures.
• QMS Compliance: Maintain compliance with ISO standards (9001, IATF 16949, or ISO 13485); support audits and update quality procedures.
• Continuous Improvement: Use Lean and Six Sigma techniques to analyze quality data, drive process improvements, and report quality metrics.

Qualifications:
Bachelor's degree in engineering or related field, with experience in CAPA, root cause analysis, and quality standards in a regulated environment.