Quality Systems & Sustaining Engineer — ISO 9001 Leader

Opti Staffing; Tigard (OR); On-site; USD 72,000 - 88,000; Full time

Job summary

Opti Staffing is seeking a Quality Systems & Sustaining Engineer in Tigard, OR. This office-based role focuses on owning the ISO 9001 QMS, leading audits, CAPA, and continuous improvement initiatives across manufacturing operations.

You will collaborate with Engineering, Manufacturing, and Supply Chain to drive quality improvements, manage calibration programs, and support MRB activities. A strong background in quality systems and documentation is essential.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years of quality engineering in manufacturing.
• Strong ISO 9001 experience.
• Experience leading audits (internal and external).
• CAPA and root cause analysis expertise.
• Technical writing and document control experience.
• Experience with calibration programs and quality systems.

Responsibilities

• Own and maintain ISO 9001 Quality Management System (QMS).
• Lead internal, external, customer, and surveillance audits.
• Drive CAPA using 8D, 5 Why, Fishbone, Pareto, and FMEA methods.
• Investigate customer complaints, supplier quality concerns, RMAs, and non-conformances.
• Manage calibration and metrology programs for inspection equipment.
• Support MRB activities and non-conforming material processes.
• Lead continuous improvement projects using Lean, Kaizen, 5S, and Six Sigma.

Skills

Quality engineering

ISO 9001

Auditing

CAPA

Technical writing

Document control

Calibration

GD&T

Project management

Communication

Education

Bachelor's degree in engineering, manufacturing, quality, industrial engineering, or related field

Job description

Opti Staffing is seeking a Quality Systems & Sustaining Engineer in Tigard, OR. This office-based role focuses on owning the ISO 9001 QMS, leading audits, CAPA, and continuous improvement initiatives across manufacturing operations.

You will collaborate with Engineering, Manufacturing, and Supply Chain to drive quality improvements, manage calibration programs, and support MRB activities. A strong background in quality systems and documentation is essential.