Title: Senior Engineer QA/QC

Company: Exentec

Location: Sherwood, OR

Exentec was established as a global leader in the delivery of mission-critical and integrated solutions for high-tech industries. We empower our customers through turnkey technologies and services that drive performance, sustainability, and growth across the entire facility lifecycle.

With a focus on reliability, risk-awareness, and innovation, Exentec embraces energy-efficient designs, automation, and advanced production. By supporting our clients in a rapidly evolving marketplace, Exentec represents technological excellence. The business is dedicated to excellence, expertise, and experience through cutting-edge technology which meet the growing demands of tomorrow’s industries.

Exentec is committed to shaping a safer, smarter, and more connected future - powered by the passion, expertise, and dedication of our people.

SUMMARY

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.

DUTIES AND 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

KNOWLEDGE, SKILLS AND ABILITIES

• 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.

EDUCATION

• Education: Bachelor’s degree in an Engineering discipline (Mechanical, Electrical, Chemical, or related) or equivalent work experience.

PREFERRED SKILLS

• 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.

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