Lead Software Validation Engineer – Med Devices

Medline Industries, LP; Illinois; Hybrid; USD 101.000 - 152.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Continuing education and training

Employee Resource Groups

Employee Service Corp

Zusammenfassung

Medline Industries, LP is seeking a leadership-level professional to drive validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner.

The role focuses on designing and implementing validation strategies across software, process, and facility domains, coordinating cross-functional teams, and maintaining quality records in a medical device QMS environment, including FDA and ISO standards.

Qualifikationen

• Bachelor’s degree in Engineering, Quality, Business, or Computer Science.
• At least 5 years of experience in Manufacturing, Quality or Engineering.
• At least 3 years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating.
• Direct experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, Electronic Records/Signatures.

Aufgaben

• Evaluate systems and applications to design validated software, processes, automation, cleaning, facility, and utility system validations.
• Design, develop, and implement test strategy, plans, scripts, and procedures to meet requirements.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with professional written communication.

Kenntnisse

Project management

Leadership

Communication

Software validation

Ausbildung

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

Tools

AS400

MS Word

MS Project

Excel

Jobbeschreibung

Medline Industries, LP is seeking a leadership-level professional to drive validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner.

The role focuses on designing and implementing validation strategies across software, process, and facility domains, coordinating cross-functional teams, and maintaining quality records in a medical device QMS environment, including FDA and ISO standards.