Neha Unnikrishna
Quality Assurance & Regulatory Affaris Engineer @Doctor Pack India Pvt. Ltd
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WORK HISTORY
Quality Assurance & Regulatory Affaris Engineer @Doctor Pack India Pvt. Ltd
Bengaluru, IN
A detail-oriented and results-driven Quality Assurance Engineer with experience in medical device manufacturing, ensuring compliance with ISO 13485, ISO 9001, ISO 14001, and ISO 45001 standards. Skilled in internal auditing, supplier audits, and regulatory inspections, with a proven track record of successfully leading audits with TUV SUD and multiple clients. Adept at handling CAPA, customer complaints, deviation management, and process optimization to enhance product quality and compliance.Certified Internal Auditor for ISO 13485 by TUV SUD and ISO 14001 & 45001 by SGS. Passionate about continuous improvement, quality excellence, and maintaining good manufacturing practices in cleanroom environments. Proficient in quality management systems (QT9-e QMS), documentation control, and analytical review. Strong engineering background with hands-on expertise in Python, MATLAB, Fusion 360, and ANSYS.Committed to driving operational efficiency and regulatory adherence in dynamic, fast-paced environments. Always eager to innovate and contribute to high-quality standards in healthcare technology.
EDUCATION
Srinivas Institute of Technology, Mangalore
Bachelor of Engineering, Aeronautical Engineering
Vivekananda
Pre-University College, Physics, Chemistry, Mathematics, Biology
Visvesvaraya Technological University
Bachelor of Engineering - BE, Aeronautical Engineering
ABOUT NEHA UNNIKRISHNA
At Doctor Pack India Pvt Ltd, a leading medical device manufacturing organization, I have been serving as a Quality Assurance Engineer since November 2023, and over the course of 2 years, I have had the opportunity to immerse myself deeply in various facets of quality management, regulatory compliance, and process improvement initiatives. My primary responsibilities include the preparation, maintenance, and revision of Quality Management System (QMS) documents such as Standard Operating Procedures (SOPs), Work Instructions, and Protocols in strict accordance with ISO 13485:2016 and ISO 9001:2015 standards. Ensuring these documents are accurate, up-to-date, and reflective of the organization\'s operations is crucial in maintaining audit readiness and compliance integrity. Additionally, I have worked diligently to support and sustain our Environmental Management System (EMS) in line with ISO 14001:2015 and Occupational Health & Safety (OH & S) programs aligned with ISO 45001:2017 requirements, emphasizing not only product quality but also environmental sustainability and employee safety.
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