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Tier-1 employer and Bangalore location increase applicant density despite specialized medical device QA skillset.
Regulatory medical-device expertise (ISO, IEC, MDR) limits cross-industry transferability.
Explicit 8–10 years and mandatory medical-device regulatory and ISO competencies create stringent shortlisting filters.
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Lead quality management for design controls and product design history files in medical device development and sustaining projects.
Drive integration of risk management processes throughout product lifecycle, including post-market surveillance and quality system initiatives.
Analyze engineering data to identify gaps between project work and quality management systems; transfer quality deliverables to manufacturing and supplier quality teams.
Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
8-10 years of experience in Quality Engineering, Safety Engineering, R&D Engineering or equivalent roles.
Mandatory knowledge of ISO 14971, 21 CFR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards.
Onsite role requiring presence at company facilities at least 3 days per week.
Experienced in leading design quality management and integrating risk management with quality systems in medical device contexts.
Skilled in data analysis, root cause analysis, CAPA methodologies, and regulatory requirements adherence.
Capable of collaborating across engineering, manufacturing, supplier quality, and regulatory teams to ensure compliance and continuous improvement.