Software Quality Assurance (SQA) Specialist – Healthcare / Regulated Environment

Position Summary

We are seeking an experienced Software Quality Assurance (SQA) Specialist to support regulatory compliance and quality assurance activities for healthcare products within a regulated environment. This role will be responsible for executing Software Development Lifecycle (SDLC) quality activities, supporting validation and testing efforts, and ensuring compliance with internal quality systems and applicable regulatory standards.

The ideal candidate will bring strong experience in software quality assurance, testing execution, defect lifecycle management, and regulated industry compliance, with the ability to work cross-functionally and independently drive projects to completion.

Key Responsibilities

• Ensure regulatory and quality compliance for healthcare software products and systems
• Execute and support SDLC quality activities, including authoring, reviewing, and approving required deliverables
• Perform end-to-end manual and/or automated testing activities including functional, regression, integration, and User Acceptance Testing (UAT)
• Manage and track defect lifecycle activities through resolution
• Support risk management activities and review documentation to identify, reduce, or eliminate risk
• Ensure adherence to Quality System requirements, policies, procedures, and regulatory standards
• Identify, escalate, and address non-compliance issues in alignment with site and corporate quality procedures
• Collaborate cross-functionally with Quality, IT, Engineering, Regulatory, and business stakeholders
• Contribute to project planning, milestones, timelines, and successful project execution
• Provide guidance and support to QA professionals, technicians, and contractors as needed
• Participate in continuous improvement initiatives related to quality systems, testing, and compliance processes
• Communicate project updates, risks, and recommendations effectively to stakeholders and leadership
• Support validation and compliance activities within Agile and/or cloud-based software environments

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline; equivalent experience may be considered
• Minimum 5 years of experience in Quality Assurance, Software Quality Assurance, or related field
• Experience working within regulated healthcare, medical device, pharmaceutical, or life sciences environments
• Strong understanding of SDLC activities and defect lifecycle management
• Experience executing manual and/or automated software testing
• Demonstrated quality mindset with strong ownership and accountability
• Ability to quickly learn and navigate existing systems and processes
• Strong communication and cross-functional collaboration skills
• Proven history of successful project execution and positive compliance outcomes