• Support quality initiatives, compliance objectives, and quality planning activities
• Participate in internal and external audits as a member of the site Audit Team
• Support design control activities for new and existing products
• Conduct risk assessments using FMEA, FMECA, Fault Tree Analysis, Hazard Analysis, and equivalent methodologies
• Lead and support process and test method validations, including IQ, OQ, and PQ activities
• Develop and maintain quality documentation, including procedures, SOPs, ETRs, drawings, equipment specifications, and technical reports
• Perform root cause analysis, process capability studies, and continuous improvement activities
• Conduct and interpret statistical analyses including DOE, Correlation & Regression, Acceptance Sampling, and Gage R&R studies
• Ensure compliance with corporate, state, federal, and regulatory requirements
• Support cross-functional quality projects and travel as required for audits, validations, training, and process-related activities