Quality Engineer 2

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.
• Cook with design transfer quality deliverables.
• Review verification/validation protocols and reports for cGMP compliance and support gap closure.
• 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.