Skills
Experience Level
Intermediate
Intermediate
Language
English
Fluent
Work Experience
Supplier Quality Engineering Team Lead - Manufacturing Transfer at Philips
August 1, 2023 - October 1, 2024Led and supported manufacturing transfer projects by reviewing and approving IQ/OQ/PQ validation protocols based on risk assessment and statistical analysis (Cp, Cpk, confidence intervals, and reliability). Authored Tooling Qualification Protocols and ensured qualification of testing tools in the laboratory, including software validation for tensile and compressive test equipment. Conducted packaging verification testing for sterile barrier systems and protective packaging, including biocompatibility and shipping-related packaging validation to ensure compliance during manufacturing transfers. Managed database systems for Manufacturing Instructions, Manufacturing Specifications, work orders, and sterilization documentation to ensure a seamless transition during process transfers. Provided hands-on leadership in qualification and validation activities while effectively collaborating with engineering, R&D, and operations teams to ensure a smooth manufacturing transfer process.
Project Engineering Team Lead - EU MDR Project / Remediation Project at Johnson & Johnson
December 1, 2021 - July 1, 2023Led EU MDR remediation activities, ensuring compliance with new regulatory standards. Developed and maintained records for regulatory requirements, managed cross-functional teams for gap assessments and trace matrix documentation. Provided guidance on Sterilization and Packaging validation, ensuring compliance with ISO 13485 and FDA regulations. Worked on risk table assessments, identifying impacts and deviations related to product changes. Senior Quality Engineer & Team Lead supporting a remediation project by leading the validation of CAPAs to ensure compliance with FDA quality standards. Collaborated with a cross-functional team to design, revise, and analyze CAPA processes, including execution strategies and project plans for effective CAPA implementation. Conducted investigations, root-cause analysis, and continuous improvement initiatives to strengthen compliance and quality systems. Led validation activities during manufacturing transfer projects, ensuring proper Design Verifica
Sr. Quality Engineer – New Product Introduction / Software Quality at Flextronics
May 1, 2021 - December 1, 2021Supported Test Method Validation (TMV) and process development for new product introduction. Conducted equipment qualification and participated in Computer Systems Validation for SAP and other business systems. Supported internal and external audits and periodic reviews, ensuring compliance with regulatory standards. Collaborated with cross-functional teams to develop and improve SOPs and GDP. Extensive experience in validating automation software used in the manufacturing process of medical devices, ensuring compliance with FDA, ISO 13485, and GAMP 5 guidelines. Worked with cross-functional teams to troubleshoot and resolve validation-related issues, maintaining accurate documentation and records of all validation activities. Developed and improved validation procedures and protocols, ensuring alignment with industry standards and best practices. Authored key validation documents, including URS, FRS, Risk Assessments, Configuration and Design Specifications, and CSV test protocols in
Sr. Supplier Quality Engineer – New Product Development at Medtronic Neurosurgery, Jacksonville, FL
December 1, 2019 - April 1, 2021Led supplier management activities for new product development, including verification, validation, and regulatory compliance. Developed and executed validation protocols, root cause analysis, and risk management for product and process design. Collaborated with suppliers on process specifications, First Article Approvals (FAAs), and CpK analysis for critical parameters. Led the development of test method validation for various testing, cleaning, sterilization methods, and process validation activities, ensuring robustness and reproducibility. Implemented risk management practices such as Design Failure Modes and Effects Analysis (DFMEA) and Process FMEA (PFMEA) across Product & Process Development Lifecycle, ensuring a proactive approach to risk mitigation. Performed statistical analysis of process data, including DOE, process mapping, control plans, and IQ/OQ/PQ validation using Minitab. Executed IQ, OQ, PQ for inspection equipment and manufacturing processes.
Supplier Quality Engineer – Stingray Manufacturing Transfer at Medtronic Neurosurgery
August 1, 2017 - November 1, 2019Led supplier audits, root cause investigations, and corrective actions (CAPA) to ensure compliance and continuous improvement in the supply chain of the new suppliers. Developed and maintained quality documentation, including Design Verification Tests (DVT), Master Validation Plans (MVP), and Master Validation Reports (MVR) to ensure validation compliance. Assisted in the qualification of new products, managed process control plans, and oversaw change control management to support seamless manufacturing transfers. Extensive experience in design, assembly, and functional testing of prototypes and parts before production, providing hands-on support to R&D teams in manufacturing transfer projects. Provided expertise in qualification and validation activities, working closely with engineering teams to ensure successful process and equipment validation during transfers. Created Preventive Maintenance (PM) documents and Standard Operating Procedures (SOPs) for testing fixtures, tools, and ma
Sr. Supplier Quality Engineer – New Product Development at Medtronic Neurosurgery
December 1, 2019 - April 1, 2021Led supplier management activities for new product development, including verification, validation, and regulatory compliance. Developed and executed validation protocols, root cause analysis, and risk management for product and process design. Collaborated with suppliers on process specifications, First Article Approvals (FAAs), and CpK analysis for critical parameters. Led the development of test method validation for various testing, cleaning, sterilization methods, and process validation activities, ensuring robustness and reproducibility. Implemented risk management practices such as DFMEA and PFMEA across Product & Process Development Lifecycle, ensuring proactive risk mitigation. Performed statistical analysis of process data, including DOE, process mapping, control plans, and IQ/OQ/PQ validation using Minitab. Executed IQ, OQ, PQ for inspection equipment and manufacturing processes.
Education
Master of Science in Engineering Technology at University of North Texas, Denton, TX
August 1, 2015 - May 1, 2017Bachelor of Technology in Mechanical Engineering at R.V.R & J.C College of Engineering, Guntur, India
September 1, 2011 - May 1, 2015Master of Science in Engineering Technology at University of North Texas, Denton, TX
August 1, 2015 - May 1, 2017Bachelor of Technology in Mechanical Engineering at R.V.R & J.C College of Engineering, Guntur, India
September 1, 2011 - May 1, 2015Qualifications
Industry Experience
Healthcare, Manufacturing, Life Sciences, Professional Services
Skills
Experience Level
Intermediate
Intermediate
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