Senior Software Validation & Quality Engineer (Med Devices)

GForce Life Sciences

United States

Vor Ort

USD 90.000 - 130.000

Vollzeit

Vor 4 Tagen

Sei unter den ersten Bewerbenden

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Zusammenfassung

GForce Life Sciences is seeking an experienced Software Validation / Quality Engineer to lead validation activities for internally developed software used in patient-matched orthopedic implants. You will establish scalable validation strategies, collaborate with Software Engineering, Quality, and Regulatory teams, and drive compliance with medical device standards.

This role requires strong documentation, risk-based validation, and hands-on execution of test plans and SOP improvements to support

Qualifikationen

5+ years of software validation, software quality, or CSV experience.
8+ years preferred
Medical device or other highly regulated industry experience
Experience validating internally developed/custom software
Strong knowledge of software validation documentation, risk-based validation, and quality systems
Experience with medical device regulations and standards strongly preferred

Aufgaben

Develop and execute software validation strategies, protocols, test plans, and documentation.
Define validation requirements based on intended use, functionality, and risk.
Support validation of internally developed software used in medical device design.
Ensure compliance with applicable medical device quality and regulatory requirements.
Develop/improve SOPs and validation processes for future software releases.
Work independently and cross-functionally to drive validation activities through completion

Kenntnisse

Software validation

Quality systems

Regulatory knowledge

Risk analysis

Documentation

Jobbeschreibung