Global Director, Software Validation & Quality (CSA/CSV)

STAAR Surgical; Lake Forest (CA); On-site; USD 200,000 - 240,000; Full time

Job summary

STAAR Surgical in Lake Forest, CA seeks Leader of Software Quality & V&V CSV/CSA to drive validation governance across SaMD and regulated software. You will lead global teams, define CSA/CSV strategy, and align with QA, Regulatory, Eng, IT to ensure compliance and scalable validation.

You will oversee lifecycle activities per IEC 62304, manage risk-based validation, and support regulatory submissions, inspections, and CAPA programs while mentoring professionals and advancing modernization of

Qualifications

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, or related discipline required or equivalent combination of education/experience.
• Advanced degree preferred.
• Relevant certifications such as ASQ CQE/CQA, RAC, ISO 13485 Lead Auditor, or cybersecurity certifications are a plus.

Responsibilities

• Lead and manage global software validation teams supporting enterprise, manufacturing, and customer-facing regulated systems.
• Define and operationalize STAAR Surgical’s Computer Software Assurance (CSA) and Computer System Validation (CSV) strategy.
• Drive transition from traditional documentation-heavy validation models toward modern risk-based CSA methodologies.
• Establish scalable validation governance supporting Agile and modern SDLC processes; ensure IEC 62304 compliance.
• Oversee validation for Oracle Fusion ERP, Salesforce eB2B/SaMD, .NET MES, and cloud applications.
• Partner with Engineering, IT, QA, Regulatory Affairs, Manufacturing, and Infrastructure teams to ensure compliant release governance.
• Ensure validation aligns with patient risk, implantable device criticality, cybersecurity exposure, and clinical impact.
• Maintain end-to-end requirements traceability across DHF, risk files, and validation evidence.

Skills

Software validation

CSA/CSV

Leadership

Regulatory compliance

Agile/SDLC

Risk management

Cybersecurity

Stakeholder collaboration

Education

Bachelor’s degree in IT/CS/Engineering/Life Sciences

Advanced degree preferred

Certifications (ASQ CQE/CQA, RAC…)

Tools

Oracle Fusion ERP

Salesforce platforms

.NET applications

Job description

STAAR Surgical in Lake Forest, CA seeks Leader of Software Quality & V&V CSV/CSA to drive validation governance across SaMD and regulated software. You will lead global teams, define CSA/CSV strategy, and align with QA, Regulatory, Eng, IT to ensure compliance and scalable validation.

You will oversee lifecycle activities per IEC 62304, manage risk-based validation, and support regulatory submissions, inspections, and CAPA programs while mentoring professionals and advancing modernization of