Director, Software Validation & Compliance (CSA/CSV)

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

Job summary

STAAR Surgical in Lake Forest is seeking a Director of Software Validation to lead software validation efforts across various platforms. The role involves managing teams, ensuring compliance with FDA regulations, and improving validation practices. Candidates should have extensive experience in software validation and a strong background in medical devices.

This leadership position requires a bachelor's degree in a related field and at least 10 years in software validation, with an emphasis on compliance and risk assessment methodologies.

Qualifications

• 10+ years of experience in regulated software validation.
• 5+ years of leadership experience managing software validation teams.
• Direct experience supporting Class III implantable medical devices preferred.

Responsibilities

• Lead and manage global software validation teams.
• Define and operationalize STAAR’s CSA and CSV strategy.
• Establish scalable validation governance for Agile processes.

Skills

Strong knowledge of FDA software guidance

Strong knowledge of software validation principles

Strong understanding of Agile validation models

Excellent analytical skills

Leadership capabilities

Education

Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences

Advanced degree preferred

Tools

Oracle Fusion ERP

Salesforce

Job description

STAAR Surgical in Lake Forest is seeking a Director of Software Validation to lead software validation efforts across various platforms. The role involves managing teams, ensuring compliance with FDA regulations, and improving validation practices. Candidates should have extensive experience in software validation and a strong background in medical devices.

This leadership position requires a bachelor's degree in a related field and at least 10 years in software validation, with an emphasis on compliance and risk assessment methodologies.