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Tier-1 employer, metro location, and a common mid-level QA title increase candidate competition.
Medical-device software quality and regulatory expertise strongly limit cross-industry transferability.
Explicit 5-7 years plus regulated medical-device software QA and domain-specific compliance skills demand strict screening.
Develop and maintain software quality documentation including Software Requirement Specifications compliant with standards and regulatory requirements.
Assess software designs and validate key design inputs such as usability, reliability, safety, and privacy to ensure compliance with quality and regulatory standards.
Oversee execution of software quality plans, conduct root cause analysis on software quality issues, and utilize post-market analytics to ensure ongoing software quality and initiate corrective actions.
Bachelor's Degree in Computer Science, Computer Applications or equivalent/Vocational Education.
5-7 years of experience in Software Quality Engineering.
Knowledge and application of global regulations and standards related to software quality and regulatory compliance.
Role requires onsite presence at company facilities at least 3 days per week for office-based teams.
Experienced in design quality management, root cause analysis, CAPA methodologies, and defect management within software development.
Proficient in applying regulatory requirements including privacy, safety, and security risk assessment throughout the software lifecycle.
Skilled in developing and reporting software quality metrics aligned with business and regulatory expectations, and capable of mentoring teams on quality engineering and compliance.