Software Quality Assurance Engineer - III

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Title: Software Quality Assurance Engineer - III
Duration: 6 Months
Location: Onsite at Lake Forest, IL

Schedule: 9 AM to 5 PM

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

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.

Role Requirements

• 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.
• Tools like Jira, Confluence, and Atlassian tools for test case management, tracking, and documentation.
• Healthcare experience is the primary industry requirement.
• Minimum 5+ years of experience working in a regulated environment.
• Strong cybersecurity knowledge is required.
• Cloud knowledge is a plus.

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.

Ideal Candidate

• Ability to gather requirements and work independently with minimal supervision.
• 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.
• Document validation activities, test results, and findings using tools like Jira, Confluence, and Atlassian tools.
• Ideally, the candidate should have experience validating software/tools within a healthcare or other highly regulated environment.

Interview Process

• 1st Round: Video interview
• 2nd Round: Onsite interview at Lake Forest, IL

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.