Dharini Patel

Background

About Dharini Patel

Seeking a position to apply my skills in an environment that enables me to achieve the highest of my abilities and gain further experience for the benefit of the organization. Experienced product engineer with a master’s in engineering management. I am also a self-starter, motivated, independent with the ability to work with cross-functional teams in an office environment and remotely. SUMMARY OF QUALIFICATION: • Experienced in making updates to the quality system for Medical device manufacturing environment, ISO 13485:2016, and 21CFR820. • Experience with Quality Systems remediation • Experience with Engineering Change Orders (ECO) • Experienced product/project management professional, with project lead experience and completion of project in scope and under budget. • Write and modify operating instructions, part specifications, incoming inspection sheet, and drawings • Conducted training on Good Documentation Practice (cGDP) per FDA guidelines • Organized and goal-oriented with a strong customer focus • Professional with contract and budgeting experience • Identify, mitigate, and monitor project risk • Computer skills include: MS Office (Intermediate/Advanced), Solidworks, ERP system software, and • QMS software (QCBD)