Quality Systems Lead (ISO 9001) & CAPA Investigator

Quanta Manufacturing Fremont; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Quanta Manufacturing Fremont seeks a Corporate Quality Engineer to execute and manage corporate quality system activities, including CAPA investigations, DCC lifecycle management, and ISO 9001 audit execution.

This role drives compliance across operations, monitors QMS performance, and collaborates cross-functionally with the Corporate Quality Management team to ensure audit readiness, non-conformance handling, and ongoing improvement.

Qualifications

• Associate's or Bachelor's degree in Quality, Industrial Engineering, Electrical, Mechanical, or related field.
• 2-6 years of corporate quality or ISO 9001 compliance experience.
• Experience in ISO 9001 certified manufacturing environment preferred.

Responsibilities

• Develop and maintain quality control and inspection processes aligned with ISO 9001 and corporate requirements.
• Manage Document Control Center (DCC) lifecycle, reviews, version control, and approvals.
• Lead root cause analyses and implement corrective and preventive actions.
• Ensure manufacturing processes meet defined quality requirements and adjust as needed.
• Lead line rejection investigations and coordinate corrective actions to prevent recurrence.
• Plan and conduct internal audits and support external/customer audits.
• Track audit findings, NCs, CAPA status, and ensure timely resolution.
• Maintain QMS performance metrics and documentation.

Skills

ISO 9001:2015 principles

Excel data analysis

Analytical problem solving

Root cause analysis (5 Whys, Fishbone)

Organizational skills

Education

Associate's or Bachelor's degree in Quality, Industrial Engineering, Electrical Engineering, Mechanical Engineering, or related field

Job description

Quanta Manufacturing Fremont seeks a Corporate Quality Engineer to execute and manage corporate quality system activities, including CAPA investigations, DCC lifecycle management, and ISO 9001 audit execution.

This role drives compliance across operations, monitors QMS performance, and collaborates cross-functionally with the Corporate Quality Management team to ensure audit readiness, non-conformance handling, and ongoing improvement.