Software Quality Assurance Engineer - III

DivIHN Integration•Lake Forest, CA

1d•Onsite

About The Position

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.

Requirements

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.
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
Strong cybersecurity knowledge is required.
Minimum 5+ years of experience working in a regulated environment.
Healthcare experience is the primary industry requirement.

Nice To Haves

Cloud knowledge is a plus.
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 supporting healthcare, medical device, pharmaceutical, or similarly regulated industries preferred.
Ideally, the candidate should have experience validating software/tools within a healthcare or other highly regulated environment.

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.
Validate software tools used and collaborate with the team in Europe.
Validate the tools as part of the testing process and develop detailed test cases.
Document validation activities, test results, and findings using tools like Jira, Confluence, and Atlassian tools.
Assess the existing software tools and determine which tools require validation.
Identify and separate the tools that need to undergo validation based on requirements and regulatory needs.
Work according to the priorities established by the Program Manager.
Develop and execute test cases for the tools selected for validation.