Sr. Analyst (ALM), Digital Quality

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

At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.

The Senior Analyst (ALM) is responsible for sustaining and continuously improving the Application Lifecycle Management (ALM) platform. This role partners with business, quality, engineering, validation, and IT stakeholders to define, implement, and optimize ALM processes that support requirements management, risk management, test management, validation documentation, traceability, workflow governance, reporting, and user adoption in a regulated medical device environment. The ideal candidate combines strong analytical skills, project management awareness, and business acumen with the ability to think broadly across the enterprise.

How you will make an impact:

• System enhancement management: Manages and monitors enhancement request backlog for Application Lifecycle Management (ALM).
• Requirement analysis and management: Act as the primary business analyst and process liaison for the ALM platform by partnering with cross-functional stakeholders to capture business needs and convert them into clear system requirements, functional specifications, workflows, reports, and configuration requests.
• Lead requirements elicitation, analysis, documentation, prioritization, and traceability activities for ALM capabilities, including requirements management, risk management, test management, review and approval workflows, baseline management, and reporting.
• Partner with Quality, R&D, Manufacturing, Software Quality, Validation, IT, and vendor teams to ensure ALM processes align with business requirements, regulatory expectations, and applicable quality system procedures.
• Support configuration design by defining tracker structures, attributes, lifecycle states, approval workflows, role-based access needs, templates, dashboards, and reporting requirements.
• Analyze current-state processes and identify opportunities to streamline, standardize, and optimize ALM workflows, reducing manual effort while improving compliance, usability, and traceability.
• Develop and maintain business process documentation, requirements documents, user stories, test scenarios, training materials, work instructions, job aids, and knowledge base content.
• Ensure defined test strategy and test plans adequately cover the requirements.
• Support user acceptance testing, defect triage, traceability reviews, evidence collection, and validation documentation reviews.
• Facilitate workshops, design sessions, stakeholder reviews, and decision discussions to gain alignment on business process design and system functionality.
• Collaborate with technical teams to troubleshoot system issues, clarify business impacts, support root cause analysis.
• Drive user adoption through training, communication, super-user engagement, best practice sharing, and ongoing support for business users.
• Support governance activities, including change impact assessments, enhancement intake, prioritization, release planning, access reviews, and process compliance monitoring.
• Act as a mentor or knowledge resource for business analysts, project team members, and super-users supporting the ALM platform.

What you'll need (Required):

• 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.

What else we look for (Preferred):

• 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.
• Result Oriented, positive “can-do” mindset with demonstration of appropriate urgency and initiative
• 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.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $81,000 to $116,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.