Senior ALM & Digital Quality Analyst (Regulated)

Regulatory Jobs; California; Hybrid; USD 81,000 - 116,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Analyst (ALM) to sustain and enhance the Application Lifecycle Management platform in a regulated medical device environment. You will partner with stakeholders across Quality, R&D, Manufacturing, Validation, and IT to define requirements, workflows, and reporting while ensuring compliance.

The role emphasizes requirements management, risk management, traceability, and achieving efficient ALM processes through documentation, testing support, and

Qualifications

• Bachelor’s degree in computer science, information systems, engineering, business admin, or related field with 5 years’ experience or
• Master’s degree with 3 years’ experience in an analyst role supporting enterprise systems.

Responsibilities

• Define, implement, and optimize ALM processes supporting requirements, risk, test, validation, traceability, workflows and reporting.
• Collaborate with cross-functional teams to align ALM with regulatory expectations (21 CFR Part 11, GxP, computer system validation).
• Lead elicitation, analysis, documentation, prioritization, and traceability for ALM capabilities.
• Drive user adoption through training, workshops, and stakeholder engagement.

Skills

ALM

Requirements analysis

Stakeholder mgmt

Documentation

SDLC

Regulatory knowledge

Education

Bachelor’s degree in CS/IS/engineering/business

Master’s degree with 3+ years

Tools

MS Office

SharePoint

Job description

Edwards Lifesciences is seeking a Senior Analyst (ALM) to sustain and enhance the Application Lifecycle Management platform in a regulated medical device environment. You will partner with stakeholders across Quality, R&D, Manufacturing, Validation, and IT to define requirements, workflows, and reporting while ensuring compliance.

The role emphasizes requirements management, risk management, traceability, and achieving efficient ALM processes through documentation, testing support, and