Staff Operational Compliance Specialist

Staff Operational Compliance Specialist 12 Months San Diego CAMust havesExpertise in 21 CFR 820 and ISO 13485Quality Management System understandingDesign Controls ExperienceJob DescriptionYou serve as the Staff Operational Compliance Specialist on key project teams, providing expertise in Quality Systems, Regulatory Compliance, and operational excellence.You drive operational compliance initiatives, including system remediation, process improvement, quality system reviews, and audit readiness activities.You proactively identify compliance and procedural gaps across programs or sites and lead corrective and preventive actions to drive sustainable improvement.You provide expert-level guidance in strengthening and governing the Quality Management System, including CAPA strategy, nonconformance management, process controls, and continuous improvement initiatives.You partner with cross-functional teams to ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.You represent the organization during internal audits and external regulatory inspections, supporting inspection readiness and regulatory responses.You ensure adherence to Quality Compliance and Regulatory Compliance requirements across products, processes, and systems.You drive enhancements within Design Controls, Pilot Manufacturing, and Manufacturing environments to improve compliance, quality system effectiveness, and operational performance.Preferred experience includes Quality Engineering, Design Controls, Manufacturing, and Validation activities. Work related years of experience: 10+ yearsEducation B.S in Science of EngineeringDay to Day ResponsibilitiesOperational compliance including:System remediationProcess improvementQuality system reviewsAudit readinessDriving enhancements in the Design Controls, Pilot Manufacturing, and Manufacturing space.Preferred Skills Remediation, Warning Letter, 483Non-Product SoftwareApplicant Notices & DisclaimersFor information on benefits, equal opportunity employment, and location-specific applicant notices, click here