Sangeetha Ramesh Email and Phone Number

• Executed quality and regulatory projects including drafting, remediating, and reviewing of various high-quality deliverables.• Reviewed number of technical documents for compliance check with regulations & standards.

• Effectively implemented & maintained QMS for international clients as per ISO 13485 & MDR requirements.• Authored & Reviewed QMS and technical documents & suggested action points. • Conducted gap assessment for various standards & regulations.• Conducted internal audits for clients to ensure QMS requirements are consistently met. • Supported clients for the external audits conducted by regulatory bodies. • Responsible for initiating and executing the CAPAs in response to non-conformances identified during external audits. • Handled various QMS software like Master control, Azena. • Dealt with various clients & served as a key liaison to communicate from managerial level.• Active co-ordination across departments to achieve desired objectives.

• Responsible for QMS department, ensured that the company’s manufacturing operations adhere to the defined process.• Created, reviewed, and updated SOPs, manual and technical files with effective implementation training.• Effectively conducted Internal/ Supplier audits, ensuring process changes and operational effectiveness.• Effectively evaluated, selected, monitored suppliers & maintained relevant documents.• Periodically conducted stability study for various products.• Developed & delivered training program for staffs, resulting in improved knowledge & skills, and increased efficiency in day-to-day operations. • Involved in Design and development, testing and licensing of new products.

• Liaising with External and Internal Customers to meet organizational Objectives.• Effectively conducted internal/ external audits and reported non- conformance to the top management.• Tasked with responsibility of SAP approval for RM, In process and Final Inspection.• Active engagement in new product development from Idea generation phase to Product evaluation.• Investigating, Resolving and Reporting non-conforming products both Internal and external.• Coordinating the supplier selection and evaluation.• Maintaining the Quality agreements for all critical suppliers and monitoring their on-going performance.• To prepare and review raw material specs/design/ drawing.• Ensuring Calibration/ external testing are followed as per schedule and documented.

• Quality testing of raw materials and samples.• Ensured the product meets the quality standard.• Reviewed BMR and other related documents.• Worked in SAP.• Maintained control samples & BMR.