Back
Specialized medical-device QA reduces applicants, but metro location and known employer increase competition.
Requires medical-device regulatory and IEC 62304 expertise, limiting cross-industry transferability.
Mandatory 5–7 years and IEC 62304/regulatory requirements enforce strict screening.
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Owns development and maintenance of software quality documentation compliant with regulatory standards across the software lifecycle.
Conducts software design assessments and root cause analyses to ensure quality, safety, and regulatory compliance, embedding quality into design.
Monitors software performance post-market, manages quality plans and risk activities, and reports key quality metrics to stakeholders.
Bachelor's degree in Computer Science or Computer Applications mandatory.
5-7 years experience in Software Quality Engineering, Software R&D, or Software Testing required.
Experience with IEC 62304/82304 standards is mandatory.
Onsite work requirement: Minimum 3 days per week presence at company facilities.
5-8 years of experience in medical device quality or R&D environment preferred.
Demonstrated expertise with medical device software regulatory standards, quality management, and risk assessment.
Operates effectively under general supervision, capable of mentoring and guiding quality engineering practices within regulated software development lifecycles.