Back
Tier-1 brand and metro location increase competition despite niche medical-device regulatory requirements.
Medical-device software quality and regulatory expertise limits role transferability across industries.
Explicit 5-7 years plus mandatory IEC 62304 and regulatory compliance create strict candidate filtering.
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Develop and maintain comprehensive software quality documentation ensuring compliance with standards and regulatory requirements.
Assess software designs and conduct root cause analysis to embed quality and resolve deficiencies in the software development process.
Monitor software performance post-market, manage software quality plans and risk activities throughout lifecycle, and report key quality metrics to stakeholders.
Bachelor's Degree in Computer Science or Computer Applications.
5-7 years of experience in Software Quality Engineering, Software R&D, or Software Testing.
Mandatory experience with IEC 62304/82304 standards.
Full-time onsite presence in company facilities as required by the role.
Experience in medical device software quality engineering or R&D, preferably 5-8 years.
Familiarity with regulatory compliance and quality management systems in healthcare software.
Technical skills including root cause analysis, CAPA methodologies, design verification and validation planning, and data analysis.