Quality Engineer 2 at Acumed LLC — Hillsboro, OR

Acumed LLC

Job Scope The NPI Quality Engineer II leads quality planning and ensures the quality of new products from development through market release. This role drives quality objectives during product development, ensuring compliance with FDA, ISO 13485, and other global standards. The QE II serves as the Quality lead during development and manufacturing, using risk management and root cause analysis to identify, assess, resolve, and communicate quality issues with limited supervision.

Responsibilities

• Represent Quality on new product development teams for design control, verification/validation, design transfer, risk management, and specifications while ensuring compliance with FDA, ISO 13485, and company requirements.
• Support engineering and manufacturing with verification, validation, and design transfer activities; define validation needs.
• Train and guide cross-functional teams on quality regulations, procedures, and requirements.
• Ensure complete, compliant Design History Files and Engineering Change Orders.
• Provide quality support throughout the product lifecycle, including CAPA, Health Hazard Evaluations, risk management, and design changes.
• Lead product risk management activities and ensure mitigation actions are completed.
• Participate in technical discussions and issue resolution using risk-based decision making.
• Process Non-Conforming Material Reports and disposition nonconforming products for new launches.
• Develop and maintain final inspection plans; support validation of inspection methods.
• Coordinate with suppliers on design transfer quality deliverables.
• Review verification/validation protocols and reports for cGMP compliance and support gap closure.
• Report progress, escalate issues, support data analysis, and prepare verification/validation reports.
• Drive continuous improvement by identifying and implementing enhancements to design and development processes.

Qualifications

• Bachelor's degree in Engineering or Science with 2+ years of quality experience in a regulated environment, or 8+ years of equivalent experience.
• Implantable medical device experience preferred.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, MDR/MDD, and related regulations.
• Experience with CAPA, root cause analysis, Six Sigma, FMEA, DOE, risk analysis, statistical methods, and trend analysis.
• Strong technical writing, communication, teamwork, and problem-solving skills.
• Proficient with SAP/ERP, Microsoft Office (advanced Excel), Minitab, and GD&T.