Senior Quality Engineer

Exyte GmbH•Portland, OR

45d

About The Position

The Senior Quality Engineer will play a critical role in ensuring the reliability and compliance of products for the semiconductor industry. This position focuses on equipment qualification, process control implementation, and failure analysis to maintain high standards of quality and regulatory compliance. The ideal candidate will have extensive experience in regulated environments and a strong understanding of engineering principles.

Requirements

Education: Bachelor’s degree in an Engineering discipline (Mechanical, Electrical, Chemical, or related) or equivalent work experience.
Experience: Minimum of 7 years in an Engineering role, with at least 3 years focused on quality engineering in a regulated environment.
Strong knowledge of ISO 9001 and other quality management systems.
Experience interpreting and applying CFR requirements.
Proven expertise in equipment qualification, process controls, and failure analysis methodologies.
Proficiency in root cause analysis tools (e.g., FMEA, 8D, Fishbone diagrams).
Excellent communication, problem-solving, and project management skills.

Nice To Haves

Experience in the semiconductor industry or related high-tech manufacturing environment.
Familiarity with statistical process control (SPC) and data analysis tools.
Knowledge of risk management principles and regulatory compliance strategies.

Responsibilities

Lead equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Develop, implement, and monitor process controls to ensure product consistency and compliance with specifications.
Conduct root cause analysis and failure investigations; implement corrective and preventive actions (CAPA).
Interpret and apply relevant sections of the Code of Federal Regulations (CFR) and other regulatory requirements.
Maintain compliance with ISO 9001 and other applicable quality standards.
Collaborate with cross-functional teams (Engineering, Manufacturing, Supply Chain) to resolve quality issues and improve processes.
Prepare and present quality reports, metrics, and recommendations to management.
Support internal and external audits, including customer and regulatory inspections.
Mentor junior engineers and provide technical guidance on quality engineering practices.
Other duties as assigned