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Chitra Nadig
Biomedical Engineer - Medical device and combination products - Quality Systems Leader
Professional Background
Chitra Nadig is an accomplished professional specializing in quality engineering, risk management, and compliance within the biomedical and software development sectors. Her extensive work experience encompasses a broad spectrum of critical roles, primarily focused on design controls, the software development lifecycle (SDLC), and regulatory compliance. At Amgen, Chitra serves as a Principal Quality Engineer, where she effectively utilizes her expertise to ensure adherence to stringent quality management systems in the development and manufacturing processes. Her career also includes significant contributions as a Risk Management Manager at Medtronic Diabetes, where she demonstrated her ability to navigate complex regulatory frameworks and manage risk assessments to enhance product safety and efficacy.
Over the years, Chitra has built a stellar reputation as a leader in quality engineering through her in-depth knowledge and practical application of ISO 13485, 21 CFR 820 Quality System Regulation, EU MDR, and IEC 62304. Her work has not only involved managing internal and external audits but also spearheading corrective actions and process improvements that ensure compliance with international standards. Chitra has played pivotal roles in post-market vigilance and managing deviations or non-conformances, contributing to the overall excellence and reliability of biomedical products.
Education and Achievements
Chitra Nadig holds a Master’s degree in Biomedical Engineering from the University of Southern California, a program renowned for cultivating skilled professionals capable of bridging engineering principles with clinical needs. This educational background laid the foundation for her impressive career in the biomedical sector.
Her achievements extend beyond her daily responsibilities; she has been instrumental in various high-stakes projects, including serving as a core team member on significant meter projects at Medtronic Minimed. Her contributions have consistently driven innovation and improved functionality in medical devices, enhancing the patient experience and establishing standards for future products. Additionally, being Green Belt certified, Chitra leads numerous process improvement initiatives, employing Lean Six Sigma methodologies to optimize operations and increase efficiencies within technical teams.
Skills
Chitra's skill set is comprehensive and refined, making her a valuable asset in any organization. Her capabilities include:
- Expertise in Regulatory Compliance: With thorough knowledge of ISO standards, FDA regulations, and quality system requirements, she ensures that all procedures adhere to regulatory expectations.
- Risk Management Proficiency: She expertly applies risk management principles, notably ISO 14971, to identify potential hazards and implement proactive measures for mitigating risks associated with medical devices.
- Human Factors Engineering: Understanding user interaction with medical devices is critical, and Chitra utilizes her skills in human factors engineering to enhance device usability and safety.
- Leadership and People Management: With a proven track record of leading cross-functional teams, she inspires and mentors her colleagues, fostering a collaborative environment that values quality and compliance.
Achievements
Chitra Nadig’s career boasts numerous achievements. As a Principal Quality Engineer, she has led teams in successfully navigating complex FDA and international regulatory submissions, ensuring that products meet the highest standards. Her ability to manage deviations and implement corrective actions has considerably reduced product risks while improving overall quality performance. Chitra's leadership on projects at Medtronic has resulted in innovative solutions that have significantly benefited the healthcare industry, thus enhancing patient care and safety. Her commitment to quality and compliance not only secures product integrity but also solidifies her reputation as a thought leader in the biomedical engineering field.
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