Senior R&D Software Quality Assurance Engineer

Job Summary

Participates as a member of the Software Quality Assurance (SWQA) team to ensure digital applications are developed, validated, and maintained in compliance with regulatory, corporate, and divisional requirements. This role involves reviewing quality system documentation as it applies to the development, verification, validation, use, and maintenance of medical device software, while coordinating activities across other engineering disciplines, departments, and contractors.

Key Responsibilities & Duties

• Compliance & Quality Tasks: Complete software quality tasks in accordance with established Quality System Requirements.
• Independent Execution: Work independently based on objectives provided by the SWQA Manager, effectively planning and coordinating daily work according to higher-level project schedules.
• Design Control Review: Review deliverables and activities identified in the Design Control Process and project plans. This includes System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices, and Verification/Validation Summary Reports for the local site.
• Defect Management: Ensure unexpected events, issues, or software bugs occurring during verification/validation are addressed and processed under relevant design control and defect management procedures.
• Regulatory Adherence: Ensure strict compliance with relevant FDA QSR, ISO guidelines (including ISO 13485 and ISO 14971), and 21 CFR Part 11 requirements as they relate to the development, verification, validation, and maintenance of medical device software.

Qualifications & Requirements

• Education: Bachelor's degree (or equivalent experience) in a scientific, technical, or engineering discipline.
• Core Experience: 2 to 5 years of experience in Software Quality Assurance and/or Software Testing.
• Project Experience: 1 to 3 years of project experience in software quality assurance practices, methodologies (including Agile), and techniques preferably with web and mobile applications.
• Technical & Regulatory Knowledge: Solid knowledge of FDA QSR, relevant ISO guidelines, and 21 CFR Part 11. Proven understanding of Design Control requirements.

Skills

• Excellent oral and written communication skills.
• ASQ Certifications are a plus.

Preferred Qualifications

• Strong preference for direct Medical Device industry experience.
• Experience with Cybersecurity, medical web/mobile applications, or Artificial Intelligence (AI) is highly preferred.