Smitha Stavos
About Smitha Stavos
Smitha Stavos is a Software Validation Quality Manager at Teleflex in Minnesota, with around 15 years of experience in software verification and validation within the life sciences and medical device industries.
Company
Smitha Stavos is currently employed at Teleflex, a medical technology company based in Minnesota, United States. She holds the position of Software Validation Quality Manager and operates in a hybrid work model. Teleflex is known for its focus on developing medical devices and technologies aimed at enhancing patient health and outcomes.
Title
Smitha Stavos serves as the Software Validation Quality Manager at Teleflex. In this role, she is responsible for managing software validations for production equipment, standalone software, and quality software in compliance with ISO 13485 and FDA guidelines. She leads a software team supporting two business units and oversees the development, implementation, and maintenance of software validation Standard Operating Procedures (SOPs).
Education and Expertise
Smitha Stavos holds a Master of Business Administration (MBA) in Project Management from Sikkim Manipal University - Distance Education, completed in 2014. She also possesses a Bachelor of Engineering (BE) in Electronics and Communication Engineering from Visveswariah Technological University, which she achieved in 2004. Her extensive expertise spans around 15 years in software verification and validation within the life sciences and medical device industries, with proficiency in various testing techniques, test documentation, and agile and waterfall development processes.
Career Background
Smitha Stavos has accumulated a diverse background in software validation and quality assurance. She began her career at Datafarm Inc as a Quality Test Engineer (2006-2009) in Bengaluru, India. She then transitioned to LIQUENT, a PAREXEL® Company, serving as a Senior Quality Assurance Engineer (2009-2013) and later as Lead Software Validation Engineer (2013-2015) in Bengaluru. Her experience expanded internationally with roles at PAREXEL in the USA as a Software Validation Engineer (2015), US Tech Solutions (2016), and various positions at Teleflex starting in 2017, culminating in her current managerial role.
Professional Achievements
Throughout her career, Smitha Stavos has managed and successfully completed numerous validation projects. She has performed 483 remediation activities on production and lab equipment, reviewed and approved software validation change orders, and provided support for both internal and external audits on software validations. Her role involves working cross-functionally on Corrective and Preventive Actions (CAPAs), demonstrating her capability in managing projects and teams with a high degree of precision and efficiency.