Senior Software Validation Lead for Medical Devices

Medline Industries, LP; Alton (IL); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Life and disability insurance

Job summary

Medline Industries, LP seeks a leader to drive validation projects across software, equipment, cleaning, and process domains in a regulated medical device/healthcare environment. You will design verification strategies, coordinate testing, and ensure alignment with customer and regulatory expectations.

The role requires coordinating multiple projects, maintaining documentation quality, and guiding teams through validation lifecycle steps in accordance with FDA and ISO guidelines.

Qualifications

• Experience in software validation within manufacturing/quality environments.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971 is preferred.
• Ability to design, author, execute and coordinate validation tests.

Responsibilities

• Evaluate systems and applications to design organized software, process, automation, cleaning, facility, and utility system validations.

Skills

Software validation

Project management

Leadership

GAMP 5 knowledge

Communication

AS400 experience

Travel readiness

Education

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

Tools

AS/400

Job description

Medline Industries, LP seeks a leader to drive validation projects across software, equipment, cleaning, and process domains in a regulated medical device/healthcare environment. You will design verification strategies, coordinate testing, and ensure alignment with customer and regulatory expectations.

The role requires coordinating multiple projects, maintaining documentation quality, and guiding teams through validation lifecycle steps in accordance with FDA and ISO guidelines.