Quality Engineer II - CAPA & Audit Lead

Creation Technologies; Everett (WA); On-site; USD 95,000 - 100,000; Full time

Job summary

Creation Technologies is seeking a Quality Engineer 2 to develop and maintain production quality standards and documentation. You will lead continuous improvement, support audits, and act as the Quality Representative within a focused team or area. The role requires Bs in Quality/Engineering and 3–7 years in quality or related engineering.

Preferred Lean Six Sigma Green Belt/ASQ certification. You will interact with multiple departments to ensure compliance with ISO 13485 and 9001 while driving

Qualifications

• Intermediate MS Office suite, Minitab; know quality tools.
• Experience with ISO 13485/9001 quality systems.
• Lean Six Sigma knowledge and problem-solving skills.

Responsibilities

• Participate in quality audits (product, process, system, supplier).
• Serve as Quality Representative within a Customer Focus Team.
• Present information to management and customers.
• Interpret assembly prints/drawings.
• Solve practical problems using root-cause analysis.
• Facilitate CAPA and corrective actions.
• Collect data and draw conclusions.
• Resolve moderate issues with 8D methodology.
• Collaborate across Engineering and Operations to meet quality goals.
• Lead internal quality meetings.

Skills

MS Office / Minitab

ISO 13485/9001

Lean Six Sigma

PFMEA & PPAP

English comms

Education

Bachelor’s in Quality/Engineering

Job description

Creation Technologies is seeking a Quality Engineer 2 to develop and maintain production quality standards and documentation. You will lead continuous improvement, support audits, and act as the Quality Representative within a focused team or area. The role requires Bs in Quality/Engineering and 3–7 years in quality or related engineering.

Preferred Lean Six Sigma Green Belt/ASQ certification. You will interact with multiple departments to ensure compliance with ISO 13485 and 9001 while driving