Senior Software Validation and Quality Engineer

GForce Life Sciences; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

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

Qualifications

• 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

Responsibilities

• 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

Skills

Software validation

Quality systems

Regulatory knowledge

Risk analysis

Documentation

Job description

We are seeking an experienced Software Validation / Quality Engineer to support internally developed software used in the design of patient-matched orthopedic implants.

This individual will lead software validation activities, establish a scalable validation approach, and partner closely with Software Engineering, Quality, and Regulatory teams.

Key Responsibilities:

• 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

Ideal Background:

• 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