Software Validation Engineer (Healthcare) - Only On W2

Job Description

Job Description

Position Summary

The Software Quality Assurance Engineer III will be responsible for ensuring regulatory compliance and quality assurance for healthcare software products. This role focuses on supporting quality system compliance activities, software validation efforts, risk management processes, and regulatory requirements within a highly regulated healthcare environment. The ideal candidate will work independently, partner with cross-functional teams across multiple geographic locations, and help ensure that software solutions are compliant, practical, innovative, and aligned with organizational objectives.

This individual may lead quality initiatives and represent the QA function on cross-functional project teams while supporting the ongoing effectiveness of Quality Systems, key processes, and regulatory compliance programs.

Key Responsibilities

• Ensure regulatory compliance for healthcare software products and related quality processes.
• Support and maintain Quality System effectiveness by identifying, addressing, and documenting non-compliance issues.
• Perform software quality assurance and testing activities within a regulated environment.
• Create, review, and maintain risk management documentation to evaluate and mitigate product risks.
• Collaborate with cross-functional teams to ensure product safety, effectiveness, and compliance throughout the development lifecycle.
• Participate in quality and compliance initiatives that support organizational and regulatory objectives.
• Provide quality oversight and guidance for software development and validation activities.
• Contribute to project execution and represent QA on cross-functional teams as needed.

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a closely related discipline; equivalent combination of education and experience may be considered.
• Minimum 5 years of experience in a Quality Assurance or Quality-related role.
• Experience performing software testing in a regulated industry environment.
• Strong understanding of healthcare industry standards, regulations, and regulatory agencies.
• Demonstrated experience with risk management methodologies and product compliance activities.
• Ability to work independently and take ownership of assigned responsibilities.
• Proven ability to collaborate effectively with cross-functional teams across multiple locations.

Required Skills

• Software Quality Assurance and Testing
• Regulatory Compliance in Healthcare/Medical Device Environment
• Quality Systems and Compliance Management
• Risk Management and Documentation
• Cross-Functional Team Collaboration
• Independent Problem Solving and Ownership
• Product Safety and Effectiveness Evaluation

Preferred Qualifications

• Knowledge of Software Development Lifecycle (SDLC)
• Experience with Cloud-Based Software Applications
• Understanding of Cybersecurity Standards and Requirements
• Experience supporting regulated healthcare software development projects

Experience

• 5+ years of Quality Assurance or Quality-related experience within a regulated environment.
• Experience supporting healthcare, medical device, pharmaceutical, or similarly regulated industries preferred.

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.

At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Kyyba is an Equal Opportunity Employer.

Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b

Company Description

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.\r\n\r\nAt Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.\r\n\r\nKyyba is an Equal Opportunity Employer.\r\n\r\nKyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b