Rinkal Shah

About Rinkal Shah

Focused and determined Quality professional & leader with great experience in managing people, operations, processes, and communications. Focused Quality professional offering strengths in team training, management, and monitoring. Dedicated to improving system procedures and controls to maximize quality and minimize errors. Observant and detail-oriented in monitoring and improving production activities. Looking to grow and contribute as a Quality professional to make meaningful impact to the industry.• Self-motivated Biomedical Engineer with a strong academic background and hands-on experience in Medical devices. • Demonstrated ability to work in an interdisciplinary team setting having worked in cross-functional teams in academic and industrial research teams• Excellent project management and time management skills leading to timely completion of various academic and industrial projects leading to 3 publications

Experience

1. Qc Manager

   Catalent

   Jul 2023 — Present · Chelsea, MA, US

   Participated in regular management review meetings, providing updates on quality control performance and suggesting areas for improvement.• Updated quality control standards, methods, and procedures to meet compliance requirements.• Followed quality standards and procedures to minimize errors and maximize client satisfaction.• Managing and working with client for weekly meetings, ensuring timely execution of client requests by coordinating effectively with internal departments and external partners.• Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.• Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.• Improved team productivity with regular communication and progress updates, fostering a collaborative work environment.• Managed project timelines for successful completion, ensuring milestones were met and deadlines were adhered to.• Managing stability program for clients including drafting stability protocols, creating new studies and setting down those studies.• Assist in job ladder creation/implementation for Quality.• Implemented an activity-based head count (HC) model that allows for quicker calculations of HC needs based on forecast changes.• Experience working with Non-Conformances, Deviations, Lab investigations and out of specifications.

Education

• University of Massachusetts Lowell

  Master's degree, Biomedical engineering & Biotechnology

  2017 — 2019

• Government Engineering College,Gandhinagar

  Master of Engineering (M.Eng.), Biomedical/Medical Engineering

  2014 — 2016

• Government Engineering College,Gandhinagar

  Bachelor of Engineering (B.E.), Biomedical/Medical Engineering

  2010 — 2014

Skills

• Microsoft Office
• Leadership
• Public Speaking
• Healthcare
• Hospitals
• Biomedical Engineering
• Research
• Matlab
• Medical Devices