Quality Engineer II

Job Title: Quality Engineer II Location: Columbia, OH Duration: 06 Months Job Description: Quality Engineer II will support Quality Systems, process controls, validation, change management, investigations, and compliance activities within a regulated medical device manufacturing environment. Key Responsibilities: Support and maintain Quality Management Systems, including change control, validation, calibration, maintenance, and environmental monitoring. Lead and participate in cross-functional quality investigations and root cause analysis. Develop, review, and approve SOPs, validation protocols/reports, specifications, quality plans, and other QMS documentation. Support product/process transfers, design changes, and manufacturing improvements from a quality perspective. Manage change controls, quality impact assessments, and implementation activities. Perform statistical analysis, quality trending, SPC, and data-driven evaluations. Support CAPA, nonconformance, complaint, and quality event investigations. Support internal, customer, regulatory, and ISO audits. Ensure compliance with FDA QMSR/21 CFR Part 820, 21 CFR Part 11, ISO 13485, EU MDR, and applicable regulations. Support critical quality programs such as calibration, preventive maintenance, and environmental monitoring. Work independently and collaborate effectively with cross-functional teams. Qualifications: Bachelor's degree in Engineering, Science, or a related field; Master's preferred. Experience in Quality Engineering within medical devices or another regulated industry. Strong knowledge of Quality Systems, change management, validation, data integrity, and regulatory requirements. Experience with statistical analysis, sampling plans, SPC, and quality trending. Strong documentation, communication, organizational, and problem-solving skills. Experience with electronic QMS, ERP systems, and Microsoft Office. ASQ, RAPS, or related certification is preferred. Ability to work independently with minimal supervision. #J-18808-Ljbffr