Harshith G Email & Phone Number

Experienced Design Quality Engineer with over 5+ years of experience enhancing quality systems to ensure compliance with regulations such as 21CFR820, ISO 13485, and EU MDR. Proficient in conducting risk analysis activities and supporting product development teams in design control, verification/validation, and risk management. Skilled in ensuring compliance of Design History File (DHF) documentation and coordinating test protocols for product remediation. Capable of providing quality engineering direction using tools like root cause analysis, FMEAs, and validation plans. Additionally, experienced in managing CAPA activities, supporting equipment qualification, and conducting routine testing to ensure quality standards.