Principal Software Quality Assurance Engineer

Position SummaryThe Principal Software Quality Engineer is responsible for executing and leading quality assurance activities within Abbott Diagnostics to ensure the delivery of high-quality, compliant healthcare software products. This role focuses on regulatory compliance, software quality processes, risk management, and cross-functional collaboration to support successful project outcomes.Key ResponsibilitiesQuality Assurance & ComplianceEnsure compliance with applicable regulatory standards and internal quality system requirementsMaintain and enhance the effectiveness of Quality Management Systems (QMS)Identify, escalate, and resolve non-compliance issues in a timely mannerSupport adherence to corporate, division, and site-level policies and proceduresSoftware Quality ExecutionExecute Software Development Lifecycle (SDLC) activities, including defect lifecycle managementDevelop, review, and approve quality deliverables and documentationPerform end-to-end testing, including functional, regression, and user acceptance testing (UAT)Support both manual and automated testing processesProject Leadership & CollaborationDefine project goals, timelines, and deliverablesLead or contribute to cross-functional projects and initiativesCommunicate effectively with stakeholders, including management and project teamsProvide guidance, training, and oversight to QA professionals and contractorsRisk ManagementEvaluate product safety, quality, and performance risksDevelop and review risk management documentationEnsure risk-based decision-making aligned with regulatory and quality standardsRequired QualificationsBachelor’s degree in Life Sciences, Engineering, or a related discipline (or equivalent combination of education and experience)Minimum of 5 years of experience in Quality Assurance or a related fieldProven experience in regulated environments, preferably within the healthcare industryDemonstrated ability to deliver successful projects and ensure compliance outcomesPreferred QualificationsKnowledge of Software Development Lifecycle (SDLC) methodologiesExperience with cloud-based software applicationsFamiliarity with cybersecurity standardsExperience working in Agile development environmentsPrior experience with ALM tools (experience within Abbott environments is a plus)Key SkillsStrong understanding of QA processes and defect lifecycle managementHands-on experience in manual and automated testingStrong ownership and accountability mindsetAbility to quickly adapt to existing systems and processesExcellent communication and stakeholder management skills