Gobind Jayesh

I've been working as a Quality Assurance and Regulatory Affairs Engineer for Medical Device Manufacturers for the past two years. Currently I'm in search for a job in Dubai, Abu Dhabi or Sharjah.

Company: Dr. Pack India Pvt Ltd

Designation: Engineer - Quality Assurance, QMS, and Regulatory Affairs

Job responsibility

•  Establish Policies in-line with company mission and values.
• Prepare and update QHSE system procedures, work instructions, standard operation procedures (SOPs) and formats as per requirement.
• Assist in the development, implementation and monitoring of Integrated QHSE Management System that complies with Company policies and procedures as well as client requirements.
• Planning and conducting QHSE internal audit in accordance with guidelines as per ISO Standards. 
• Conducting On-site Supplier/Vendor QHSE Audits. 
• Conduct incident investigations and analysis to identify the root cause of incidents, provide appropriate corrective actions and prepare/submit lessons learned to the QHSE Manager.
• Initiate, Review, and finalize the projects/Activities/Services Risk Assessment, Environmental Aspect & Impact Register.
• Assist in the preparation of legal & compliance register and to support all departments and the company to be in conformance with relevant legislations and mandated requirements.
• Responsible for Regulatory Compliance and preparation, review and timely submission of dossiers to various agencies.
• Handle customer complaints and implement Corrective and Preventive action using Quality tools like Pareto, Control Charts & verifying its effectiveness.
• Provides regulatory guidance to regulatory associates & other departments.

EDUCATION and TRAINING

• Bachelor of Technology in Mechanical Engineering

CERTIFICATIONS

• Lead Auditor Certification in ISO 9001:2015
• Internal Auditor Certification in ISO 45001:2018 and 14001:2015