IT BRM: Complaint Process Automation Lead

Thornton Tomasetti; Alameda (CA); On-site; USD 131,000 - 261,000; Full time

Benefits offered by this job

Health Insurance

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking an IT Business Relationship Manager for Complaint Process Automation located in Alameda, CA. This role drives digital transformation in Post-Market Surveillance, gathering requirements, documenting processes, and coordinating testing while partnering with Quality, Regulatory, Operations and IT to deliver compliant, efficient technology solutions.

You will serve as the liaison between business stakeholders and IT, leading cross-functional initiatives from concept through

Qualifications

• Bachelor’s degree in computer science, Engineering, or related field.
• 10 years of experience in automation, IT business alignment, or Quality operations.
• Strong business process defining experience including current and future process mapping state e.g business value propositions, etc.
• Knowledge of FDA regulations, ISO 13485, MDR, CAPA, Complaint Handling, and Quality Management Systems.
• Post-Market Surveillance (PMS) and complaint handling knowledge.
• Exposure to cloud-based remote process automation (RPA) deployments like Automation Anywhere, UI Path etc.
• RPA certifications (e.g., UiPath Certified Developer, Automation Anywhere Advanced RPA Professional) preferred.
• Familiarity with Six Sigma, Lean, or other continuous improvement methodologies.
• Exposure to launching automation solutions in the Health Care or Med Device industry.

Responsibilities

• Gather, analyze, and document business requirements, functional specifications, business rules, and process workflows.
• Facilitate requirements, workshops and stakeholder discussions.
• Develop business cases, process maps, use cases, and acceptance criteria.
• Serve as the primary liaison between business stakeholders and technical teams to ensure successful delivery.
• Ensure requirements are traceable, prioritized, and aligned with strategic business objectives.
• Lead cross-functional initiatives from concept through deployment and operational stabilization.
• Develop business cases, requirements, implementation of roadmaps, and success metrics.
• Coordinate with IT organizations, vendors, and business teams to ensure timely and compliant solution delivery.
• Support user acceptance testing, validation activities, change management, and training efforts.
• Manage project risks, dependencies, and stakeholder communication throughout project lifecycles.
• Drive execution of strategic initiatives aligned with business and technology priorities.
• Establish scalable business process automation standards, governance frameworks, and automation best practices.
• Analyze current workflows and identify automation opportunities to improve accuracy, compliance, productivity, and throughput.
• Design and implement automation solutions utilizing enterprise platforms and emerging technologies.
• Define automation integration touchpoints across enterprise applications to ensure seamless data flow and traceability.
• Evaluate and recommend emerging technologies, AI, workflow automation, and digital solutions that support business transformation initiatives.
• Deliver automation capabilities that improve productivity, reduce cycle times, enhance quality, and lower operational costs.
• Analyze current-state business processes and identify opportunities for standardization, simplification, and automation.
• Design future-state business processes, operating models, governance frameworks, and business capabilities.
• Develop process architectures, value streams, operational roadmaps, and transformation strategies.
• Support implementation of operational controls, monitoring mechanisms, and process performance metrics.
• Drive continuous improvement initiatives utilizing Lean, Six Sigma, and industry best practices.
• Align business process design with enterprise architecture and technology strategies.
• Support project planning, roadmap development, milestone tracking and risk management activities.
• Coordinate project deliverables, resource planning, business readiness, and deployment activities.
• Assist project managers and business leaders in successful project execution.
• Monitor action items, decisions, dependencies, and project outcomes.
• Support implementation, cutover, go-live, hypercare, and operational transition activities.
• Drive change management, training, adoption, and business readiness effort
• Develop test strategies, test scenarios, test scripts, validation plans, and acceptance criteria.
• Coordinate User Acceptance Testing (UAT), validation activities, and business verification processes.
• Document testing results and support issue identification, prioritization, and defect resolution.
• Ensure delivered solutions meet documented business requirements and compliance standards.
• Support validation of lifecycle activities in regulated environments.
• Develop executive presentations, project status reports, dashboards, scorecards, and performance metrics.
• Maintain project documentation, requirements repositories, business procedures, and operational documentation.
• Track key performance indicators and communicate progress to leadership and stakeholders.
• Support internal audits, inspections, compliance reviews, and documentation requests.
• Prepare business and operational reports that support data-driven decision making.
• Ensure alignment of business processes with FDA, ISO 13485, MDR, and other applicable regulatory requirements.
• Ensure solutions comply with Abbott quality standards, cybersecurity requirements, and applicable regulations.
• Maintain policies, procedures, and documentation required for audits and inspections.
• Support validation, change control, and system lifecycle management activities.
• Promote governance standards that support sustainable, scalable, and compliant business processes.
• Collaborate with Quality, Regulatory, Privacy, and Information Security teams on risk mitigation strategies.

Skills

Business process definition

Requirements gathering

Stakeholder liaison

IT-business alignment

Process automation

Risk management

Education

Bachelor’s degree in computer science, Engineering, or related field

Job description

Abbott is seeking an IT Business Relationship Manager for Complaint Process Automation located in Alameda, CA. This role drives digital transformation in Post-Market Surveillance, gathering requirements, documenting processes, and coordinating testing while partnering with Quality, Regulatory, Operations and IT to deliver compliant, efficient technology solutions.

You will serve as the liaison between business stakeholders and IT, leading cross-functional initiatives from concept through