Quality Engineer

Quality Engineer

Quality Engineer - Citizen Only Location : Milwaukie, OR (onsite 5 day a week)

Minimum of 10 years of experience in Quality Management.

Minimum of 5 years of experience PRI-Nadcap accreditation program.

Lead Auditor iaw AS9100 and ISO19011.

The company is seeking a hands-on Quality Engineer with experience in medical and implantable devices to support and enhance its product assurance and regulatory compliance programs. This role focuses on ensuring the quality and integrity of new and existing products in accordance with FDA, ISO, and internal standards. While there are no direct management responsibilities, the engineer will play a critical role in maintaining the company's quality systems and promoting regulatory awareness across the organization.

Key Responsibilities

• Support and manage core elements of the quality system to ensure compliance with FDA regulations and ISO standards.
• Collaborate with cross-functional teams to prevent or resolve product defects in both new development and sustaining efforts.
• Drive awareness and implementation of regulatory and customer requirements across relevant functions.
• Contribute to internal and external audits, inspections, and regulatory submissions.
• Monitor and improve product and process flows for ongoing quality assurance.

Preferred Qualifications

• Experience with implantable medical devices strongly preferred.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and related quality/regulatory frameworks.
• Detail-oriented with a proactive approach to problem-solving and continuous improvement.
• Excellent communication and documentation skills.