Senior Systems Engineer

We're hiring on behalf of a Haystack partner!The Role Act as a subject matter expert for CAPA, non-conforming product, deviations, and compliance-related activities Lead the end-to-end CAPA, non-conforming product, and deviations processes, including initiation, investigation, root cause analysis, action planning, implementation, and effectiveness verification Ensure CAPA activities are compliant with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR) Monitor CAPA metrics and quality data sources trends to identify systemic issues and drive continuous improvement Facilitate cross-functional CAPA review meetings and provide guidance on investigation techniques and problem-solving methodologies Implement and promote best practices in root cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis)What You'll Need Experience leading and maintaining the effectiveness of Corrective and Preventive Action (CAPA) systems Strong understanding of global regulatory requirements and quality standards in a medical device environment Proficiency in root cause analysis and problem-solving methodologies Ability to analyze quality data and trends to proactively identify risks and opportunities Excellent communication and facilitation skills for leading review meetings and providing trainingWhat's On Offer Opportunity to drive continuous improvement in quality systems Contribute to the development of innovative healthcare solutions Work in an environment that supports and inspires individual excellenceApply via Haystack today!