Design Quality Engineer

Design Quality Engineer responsible for ensuring quality plans are made, validating design inputs, and performing independent technical assessment on product quality performance. Leads quality related problem solving and root cause analysis, and provides leadership and oversight to ensure Quality Management System Compliance.

Requirements

• Engineering Graduate in computer science engineering or related field
• Over all 12 years within technology industry and Min 08 years in Software quality management function within Medtech Industry
• Expert in ISO 13485, ISO 14971, IEC 82304, IEC 62366, EUMDR, 21CFR820
• QMSR, Software tool validation, Correction and removals
• Expert in design controls, CAPA, Compliant handling process
• Proficient in data analysis, RCA, performance dash boards, reliability engineering
• Good understanding of Software development methodology and various technologies (Cloud and platform solutions)
• Passion for patient safety and quality in fast paced Medtech industry

Benefits

• Hybrid work flexibility
• Flexible working hours