Required Attributes :Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field. 6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry. In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO.Proven experience in leading regulatory submissions and successful product

Required Skills & Experience:Technical / Domain Skills• 12-15 years of experience in software testing, with at least 3+ years in Test Management.• Strong exposure to pharma / life-sciences / healthcare domain, especially in LIMS, Clinical, or Regulatory applications.• Sound understanding of CSV, GxP, and FDA 21 CFR Part 11 compliance.• Hands-on experience with test management tools (ALM, Azure DevOps, JIRA) and automation frameworks (Selenium, Tosca,

This role is based at TKM MQE in a General Shift and involves critical work in ensuring the quality of our materials. Key responsibilities include:Material Quality Assurance and control.Supplier Interaction and Material Issue Resolution.In House Quality Check.Required Candidate ProfileWe are looking for a candidate who meets the following criteria:Vacancy: Engineer.Experience: Minimum 2-4Years.Education: BE - Chemical or Mechanical Engineering.Age Group: