Recommendations

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  Zachary Wilson _{Manufacturing & Supply Chain Manager}

  Maanya’s contributions to Exergen’s quality management and regulatory compliance goals have been invaluable over the last year. During our time working together, Maanya has played a pivotal role in ensuring adherence to ISO 13485 standards while streamlining our processes to maintain efficiency. Her ability to not only design but also implement UDI-compliant product labels has showcased a blend of technical precision and creativity. Maanya’s contributions to CAPA processes and root cause analysis were instrumental in resolving various critical challenges, demonstrating her analytical acumen and dedication to continuous improvement. Additionally, her meticulous approach to product validation and testing ensured top-notch reliability and compliance with FDA, MDR, and CE marking requirements. What truly sets Maanya apart is her skill in managing cross-functional projects, from preparing for audits and managing risk assessments under ISO 14971 standards to coordinating change control processes seamlessly. Her technical documentation skills and data-driven approach to reporting further highlight her value as a team player and problem-solver. Maanya brings not only technical expertise but also a collaborative spirit that fosters innovation and teamwork. She is an asset to any organization striving for excellence in quality and compliance.

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  Shivani Patel _{Quality & Regulatory Project Manager}

  Maanya is an exceptional team player and reliable. Her constant efforts to keep herself updated with regulatory trends always puts her apart. Her attention to details and exposure to various regulations and standards makes her a person to go to for any queries or doubts. Her expertise and strategic vision ensured our products consistently met industry regulations. If you are looking for a well-read, hardworking and seasoned regulatory professional, Maanya would be a perfect choice and an excellent addition to any organization.

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  Dale Jones _{Principal Consultant/Owner - Quality Excellence LLC}

  I had the pleasure to coach and supervise the day-to-day work of Maanya for several months during her final year at Northeastern U. She is a high-caliber professional whose passion for learning new concepts and translating that learning into applicable and tangible results was second-to-none. Maanya always completed her work (sometimes under heavy pressure and deadlines) in a most productive fashion and was creative with solutions to quality issues. Examples of her work included the re-design of our Company product labels which met compliance with EU MDR 2017/745 and ISO 13485:2016, as well as other global regulations. Also, she was instrumental in supporting the preparation of key regulatory audits. If presented with another opportunity to work with, or to hire Maanya, I would happily do so without reservation. She is a bright and thoughtful individual, and is an immediate asset to any Company fortunate enough to recognize her potential value to an organization.