Hiring: Site Quality Assurance Engineer II Company: ZOLL Medical Corporation Location: Deerfield, WI Job Posted Time: 2026-09-03 14:43:48 Employment Type: Hybrid Target Skills & Keywords : Quality Assurance, Regulatory Compliance, Root Cause Analysis About the job Experience: •5+ years of experience in quality engineering, manufacturing quality, or a related engineering role, preferably in the medical device industry Required Skills: •Lead investigations into manufacturing and process quality issues, including root cause analysis, data review, and development of recommendations to address quality concerns. •Support Material Review Board activities and nonconforming material resolution, including documentation, disposition support, and coordination with cross-functional teams. •Lead manufacturing CAPA and nonconformance investigations, including documentation, cross-functional coordination, and follow-up of corrective actions. •Analyze yield, scrap, rework, and process capability data to identify trends, recurring issues, and opportunities for manufacturing quality improvement. •Support manufacturing process validation, equipment qualification, and new product introduction readiness activities through review of documentation and participation in related quality assessments. •Partner cross-functionally with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues and implement effective solutions. •Participate in internal and external audits, inspection readiness activities, and regulatory compliance efforts to support adherence to applicable quality system requirements and internal procedures. •Ensure site quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures. Qualifications: •Bachelor’s degree in Engineering or a related technical discipline. •5 plus years of experience in quality engineering, manufacturing quality, or a related engineering role, preferably in the medical device industry. •Demonstrated experience leading investigations, root cause analysis, and manufacturing quality improvement activities. •Solid functional working knowledge of manufacturing quality systems, nonconformance management, and CAPA processes. •Knowledge of statistical process control, process capability analysis, and data-driven problem solving. •Strong written and verbal communication skills, with the ability to clearly present findings and recommendations to technical stakeholders. •Demonstrated capacity to work effectively in a hybrid or on-site environment while collaborating across cross-functional teams. •Operational familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements. •Knowledge of statistical analysis tools and manufacturing quality methodologies. •ASQ Certified Quality Engineer or similar certification is a plus. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!