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

Society of Exploration Geophysicists; Portland, Northern (OR, KY); On-site; USD 200,000 - 240,000; Full time

Job summary

STAAR Surgical seeks a Leader of Software Quality V&V CSA/CSV to oversee the company’s software validation program across regulated and SaMD platforms. You will lead global teams, shape the CSA/CSV strategy, and ensure alignment with IEC 62304, FDA guidance, and data integrity.

You will collaborate with QA, Regulatory, Engineering, Manufacturing, and IT to drive risk-based validation, robust traceability, and compliant software lifecycle governance across ERP, cloud, and custom applications.

Qualifications

• Bachelor’s degree in information technology, computer science, engineering, life sciences, or related field.
• Advanced degree preferred and relevant certifications are a plus.
• Experience with CSA/CSV, LCM, risk-based validation, and software lifecycle processes.

Responsibilities

• Lead global software validation teams supporting enterprise, manufacturing, and customer-facing regulated systems.
• Define and operationalize CSA and CSV strategy for software quality governance.
• Drive transition to risk-based CSA methodologies and modern SDLC processes.
• Ensure compliance with IEC 62304, FDA software guidance, and data integrity requirements.
• Oversee validation for ERP, CRM, MES, cloud applications, and SaMD-related platforms.
• Collaborate with QA, Regulatory Affairs, IT, and Manufacturing to align design controls and validation.
• Provide leadership and mentorship to validation engineers and cross-functional teams.
• Support inspections, CAPA, and post-market actions related to software validation.

Skills

Software Quality

CSA/CSV leadership

Regulatory Compliance

Leadership

Risk Management

Education

Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or related discipline

Advanced degree preferred

ASQ CQE/CQA or ISO 13485 Lead Auditor certifications

Tools

Oracle Fusion ERP

Salesforce platforms

.NET applications

Job description

STAAR Surgical seeks a Leader of Software Quality V&V CSA/CSV to oversee the company’s software validation program across regulated and SaMD platforms. You will lead global teams, shape the CSA/CSV strategy, and ensure alignment with IEC 62304, FDA guidance, and data integrity.

You will collaborate with QA, Regulatory, Engineering, Manufacturing, and IT to drive risk-based validation, robust traceability, and compliant software lifecycle governance across ERP, cloud, and custom applications.