Senior ALM & Quality Systems Strategist

Edwards Lifesciences Gruppe; California (MO); Hybrid; USD 81,000 - 116,000; Full time

Benefits offered by this job

Competitive salaries

Job summary

Edwards Lifesciences Gruppe in California seeks a Senior Analyst to sustain and improve the ALM platform. You will partner with quality, engineering, validation and IT to implement requirements management, risk management, test management, and documentation in a regulated medical device setting.

The role emphasizes process governance, traceability, and user adoption, with opportunities to mentor analysts and drive enterprise-wide improvements in ALM workflows.

Qualifications

• Bachelor’s or Master’s in a related field with experience in enterprise systems.
• Experience supporting enterprise systems in regulated settings (medical device/pharma).
• Strong analytical, stakeholder management, and communication skills.

Responsibilities

• Lead requirements elicitation, analysis, documentation, prioritization and traceability for ALM capabilities.
• Partner with Quality, R&D, Manufacturing, Validation, IT to align ALM with regulatory expectations.
• Define tracker structures, lifecycle states, workflows, dashboards, and reporting requirements.
• Drive user adoption through training, workshops, and super-user engagement.
• Support governance activities including change impact assessments and release planning.
• Mentor junior analysts and collaborate with cross-functional teams to improve ALM processes.

Skills

Business analysis

ALM knowledge

Requirements management

Stakeholder management

Documentation

Regulatory compliance

Test management

Traceability

Workflow governance

Training & adoption

Education

Bachelor's degree in computer science, information systems, engineering, business administration, or related field

Master’s degree, with 3+ years in analyst/BA/Product Owner

Tools

Microsoft Office (Word/Excel/PowerPoint)

SharePoint

Microsoft Teams

ALM/SDLC tooling

Job description

Edwards Lifesciences Gruppe in California seeks a Senior Analyst to sustain and improve the ALM platform. You will partner with quality, engineering, validation and IT to implement requirements management, risk management, test management, and documentation in a regulated medical device setting.

The role emphasizes process governance, traceability, and user adoption, with opportunities to mentor analysts and drive enterprise-wide improvements in ALM workflows.