Senior Software Validation Quality Engineer

United Pharma; Indiana; On-site; USD 110,000 - 170,000; Full time

Job summary

United Pharma is seeking a Senior Software Validation Quality Engineer to lead validation of internally developed software used in design of patient-matched orthopedic implants. The role demands hands-on execution and scalable processes for future updates.

The ideal candidate has 5+ years in software validation or quality within a regulated medical device environment, with 8+ years preferred, and can work independently to establish SOPs, documentation, and traceability.

Qualifications

• 5+ years experience in software validation or software quality.
• Experience in a regulated medical device environment preferred.
• Strong understanding of formal software validation processes and documentation.

Responsibilities

• Lead and support validation of internally developed software used in the design and development of patient-matched orthopedic implants.
• Develop and execute validation strategies, protocols, test plans, and documentation.
• Define validation requirements based on intended use, functionality and risk.
• Collaborate with Software Engineering, Quality, Regulatory and cross-functional teams to ensure compliance.
• Establish SOPs and processes for software validation.
• Develop a scalable validation framework for future updates and releases.
• Evaluate requirements, risk assessments, test results, deviations, and validation evidence.
• Ensure documentation and traceability throughout the lifecycle.
• Support cybersecurity, access controls, data integrity, and HIPAA/privacy considerations.
• Identify gaps and drive improvements in validation processes.
• Guide internal teams on software quality and validation expectations.

Skills

Software validation

Quality assurance

Regulatory compliance

Independent work

Documentation

Education

Bachelor's degree in Engineering/CS/Software or related

Job description

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.