Senior Software Validation Leader

Medline; Redmond (OR); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks an experienced leader to drive validation programs ensuring FDA, ISO, and GAMP requirements are met. You will lead development and execution of validation projects across software, process, and facility domains.

You will design test strategies, coordinate multiple projects, and document validation protocols while maintaining Medline policies and quality records. The role supports regulatory compliance and continuous improvement in a global medical device environment.

Qualifications

• Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• 5+ years of experience in Manufacturing, Quality or Engineering.
• 3+ years in GAMP 5 validated computerized systems.
• Experience in FDA 21 CFR Part 820, ISO 13485, ISO 14971 and software validation principles.
• Experience leading cross-functional teams and project management.
• Knowledge of QMS and ISO13485:2016, 21 CFR 11, and audits.

Responsibilities

• Evaluate systems and applications to design validated software, processes, and related validations.
• Design, develop, and implement test strategies, plans, scripts, and procedures.
• Coordinate, execute, and report on validation plans for software.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with professional writing.
• Support Medline policies and regulatory procedures.
• Maintain awareness of FDA, GAMP, ISO regulatory environment.
• Improve efficiencies in software validation and related processes.
• Support development and upkeep of Divisional SOPs for software use.
• Provide system design feedback to ensure regulatory compliance throughout SDLC.

Skills

Leadership

Project management

Regulatory knowledge

Documentation

Education

Bachelor's degree in Engineering, Quality, Business, or Computer Science

Tools

MS Word

MS Project

MS Excel

Job description

Medline Industries, LP seeks an experienced leader to drive validation programs ensuring FDA, ISO, and GAMP requirements are met. You will lead development and execution of validation projects across software, process, and facility domains.

You will design test strategies, coordinate multiple projects, and document validation protocols while maintaining Medline policies and quality records. The role supports regulatory compliance and continuous improvement in a global medical device environment.