Senior Analyst, Digital Quality

Edwards Lifesciences

. Sustain and continuously improve the Application Lifecycle Management (ALM) platform .

Posted 10/1/2026full-timeCalifornia • United StatesSenior💰 $81,000 - $116,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Application Lifecycle Management (ALM) processes, requirements elicitation, and compliance within regulated industries. Proficient in stakeholder engagement, documentation, and training to drive user adoption and optimize workflows.

Highest-signal resume keywords

Application Lifecycle Management (ALM)Requirements ElicitationRegulatory ComplianceStakeholder ManagementProcess Mapping

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Business AnalysisRequirements DocumentationProcess OptimizationTest ManagementSoftware ValidationAgile PracticesChange ControlRequirements TraceabilityProject ManagementGap Analysis

Soft Skills

Analytical SkillsProblem-SolvingOrganizational SkillsCritical ThinkingFacilitation Skills

Tools & Technologies

Microsoft OfficeWordExcelPowerPointTeamsSharePoint

Industry Keywords

Medical DeviceLife SciencesPharmaceuticalRegulated Industry21 CFR Part 11GxPComputer System ValidationAudit TrailsElectronic SignaturesGood Documentation Practices

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Sustain and continuously improve the Application Lifecycle Management (ALM) platform
Manage and monitor the ALM enhancement request backlog
Partner with stakeholders to capture business needs and convert them into system requirements, functional specifications, workflows, reports, and configuration requests
Lead requirements elicitation, analysis, documentation, prioritization, and traceability activities
Align ALM processes with business requirements, regulatory expectations, and quality system procedures
Define tracker structures, attributes, lifecycle states, approval workflows, role-based access needs, templates, dashboards, and reporting requirements
Analyze current-state processes and optimize ALM workflows to improve compliance, usability, and traceability
Develop and maintain process documentation, requirements documents, user stories, test scenarios, training materials, work instructions, job aids, and knowledge base content
Ensure test strategies and plans adequately cover requirements
Support user acceptance testing, defect triage, traceability reviews, evidence collection, and validation documentation reviews
Facilitate workshops, design sessions, stakeholder reviews, and decision discussions
Collaborate with technical teams to troubleshoot system issues and support root cause analysis
Drive user adoption through training, communication, super-user engagement, best-practice sharing, and ongoing support
Support governance activities such as change impact assessments, enhancement intake, prioritization, release planning, access reviews, and compliance monitoring
Mentor or serve as a knowledge resource for business analysts, project team members, and ALM super-users

Requirements

What you’ll need

Bachelor’s degree in computer science, information systems, engineering, business administration, or a related field with 5 years’ experience
OR Master’s degree with 3 years’ experience in an analyst, business systems analyst, product owner, or similar role supporting enterprise systems
Experience managing small projects
Experience working in a medical device, life sciences, pharmaceutical, or other regulated industry
Ability to adapt to new technology and a rapidly changing environment
Ability to interface and manage multiple stakeholders
Experience in medical devices, pharma, biotech or healthcare related industries
Understanding of business analysis practices, including requirements elicitation, process mapping, stakeholder analysis, gap analysis, and solution documentation
Knowledge of SDLC, ALM concepts, Agile practices, requirements traceability, change control, and software validation principles
Experience supporting ALM, PLM, EQMS, SDLC, validation, requirements management, test management, or regulated system implementation initiatives
Experience drafting presentations and presenting investigation and trend summaries
Understanding of regulated system expectations, including 21 CFR Part 11, GxP, computer system validation, audit trails, electronic signatures, and good documentation practices
Strong analytical, problem-solving, organizational, and critical thinking skills with attention to detail
Excellent written and verbal communication skills, including the ability to communicate with technical and non-technical audiences
Strong facilitation skills with the ability to lead workshops, drive decisions, and build alignment across cross-functional teams
Ability to manage competing priorities, work independently with minimal supervision, and deliver high-quality documentation in a fast-paced environment
Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Teams, and SharePoint

Benefits

Comp & perks

Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of employees and their families