Quality Engineer

Job Title: Quality Engineer (Medical Device)

Location: Portland, OR

Duration: 06+ Month Contract

Summary:

We are seeking an experienced Quality Engineer to support our client in the medical device industry. This role will be focused on ensuring quality compliance and continuous improvement within extrusion production lines, supporting both manufacturing and product quality requirements.

Key Responsibilities:

• Provide quality engineering support for extrusion manufacturing processes and production lines.
• Develop, implement, and maintain quality systems and procedures in compliance with FDA, ISO 13485, and other regulatory requirements.
• Conduct process validations, risk assessments, and capability studies related to extrusion operations.
• Partner with cross-functional teams including manufacturing, R&D, and regulatory to support new product introductions and ongoing production.
• Monitor and analyze non-conformances, deviations, and CAPAs; ensure timely closure with effective corrective and preventive actions.
• Perform root cause analysis and drive continuous improvement initiatives to enhance product quality and process reliability.
• Support audits (internal, external, and regulatory) by preparing required documentation and participating in inspections.
• Provide technical guidance and training to production teams on quality requirements.

Required Skills & Qualifications:

• Bachelor’s degree in Engineering, Quality, or related technical field.
• Minimum 3–5 years of Quality Engineering experience in the medical device industry.
• Strong background in extrusion manufacturing processes (preferably tubing, catheters, or similar medical device components).
• Knowledge of FDA 21 CFR Part 11/820, ISO 13485, ISO 14971, and GMP requirements.
• Experience with process validation (IQ/OQ/PQ), SPC, and statistical data analysis tools (Minitab preferred).
• Hands-on experience with CAPA, root cause analysis, FMEA, and risk management.
• Strong problem-solving, analytical, and communication skills.
• Ability to work effectively in a cross-functional and regulated environment.