Senior Software Validation Quality Engineer

Consultant, Senior Software Validation Quality Engineer, Medical Devices
Summary
Our client, a leading global medical device organization, is seeking a Senior Software Validation Quality Engineer to support the validation of internally developed software used in the design of patient-matched orthopedic implants.
Because the software is directly involved in the design process and generates technical information associated with the implant, it requires a more rigorous validation approach than traditional off-the-shelf software. This individual will help establish and execute a formal software validation strategy while creating a scalable process for future software updates and releases.
The ideal candidate will bring 5+ years of software validation or software quality experience, with a preference for candidates who have 8+ years of experience in a regulated medical device environment. This is an opportunity for a hands-on, experienced professional who can operate independently, drive the validation process, and help establish SOPs and documentation from the ground up.
Job Duties
Lead and support the validation of internally developed software used in the design and development of patient-matched orthopedic implants.
Develop and execute software validation strategies, protocols, test plans, and associated documentation.
Define validation requirements based on the software's intended use, functionality, and risk.
Partner with Software Engineering, Quality, Regulatory, and other cross-functional teams to ensure software meets applicable quality and regulatory requirements.
Establish and document standard operating procedures (SOPs) and processes for software validation.
Develop a sustainable validation framework that can be applied to future software updates, enhancements, and releases.
Evaluate software requirements, risk assessments, test results, deviations, and validation evidence.
Ensure appropriate documentation and traceability throughout the software development and validation lifecycle.
Support quality activities related to cybersecurity, access controls, data integrity, and HIPAA/privacy considerations.
Identify gaps in existing software validation processes and recommend improvements.
Provide guidance to internal teams regarding software quality and validation expectations.
Depending on experience, potentially support aspects of software development and/or software quality engineering.
Help ensure the software and associated technical information meet the quality expectations of a regulated medical device environment.
Requirements
Bachelor's degree in Engineering, Computer Science, Software Engineering, Quality, or a related technical discipline preferred.
5+ years of experience in software validation, software quality, software V&V, or a closely related field.
Experience working within a regulated environment, preferably medical device.
Strong understanding of formal software validation processes and documentation.
Experience developing and executing validation protocols, test plans, and/or test scripts.
Ability to independently drive a software validation process from requirements through completion.
Terms & Start
Remote
6-9+ month contract, possibility of extension
Benefits included: Medical, Dental, Vision
Pay: 55-60/hr

Work arrangement
Yes