Description

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

Key Skills

Education

Bachelor's degree