Rajesh Anantharaman

Experience

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  Theken Spine

  Jun 2004 - Jul 2006

  R&D/Quality Engineer

  Theken Spine, LLC founded in 1998 (now Integra Spine) designs, develops, manufactures and distributes a full range of spinal fixation products.• Collaborated with product development on design control protocols. • Conducted internal audits, evaluate vendor performance.• Administered the Corrective and Preventive Action (CAPA) system. • Assessed incoming products for conformance to design requirements.• Managed documentation per ISO-9001:2000/ISO-13485:2003, FDA and CE guidelines. • Performed customer complaint processing and returns authorization. • Member of a successful team that helped the company gain ISO 13485:2003 certifications. Show less

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  MedGyn Products

  Nov 2006 - Mar 2007

  Quality Systems Engineer

  MedGyn manufactures and distributes superior quality medical supplies, instruments, and equipment to satisfy the needs of the leading Obstetrics and Gynecological medical professionals.• Maintained the Quality System and re-certifying the company to ISO 13485:2003 and MDD 93/42/EEC certifications. • Conducted and coordinated internal audits for maintaining and improving the company’s QMS.• Performed Root Cause Analysis and implemented Corrective and Preventive Actions (CAPA) during and after audits.• Maintained and updated Product Technical Files and Design History Files (DHF) per latest regulations and standards. • Created a training program and associated skill matrix for all employees. Show less

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  Wipro

  Apr 2007 - Nov 2012

  Project Lead

  Global IT Compliance Lead for a Medical Device and Drug Manufacturer - Chicago, ILDecember 2009 to November 2012Project Engineer for the Engineering Design Services group- Bangalore, IndiaJuly 2009 to November 2009Drafted a White Paper titled "Medical Device Product Recalls and Quality Enhancements" which was published in the Knowledge Management Portal.Previously, in Europe, identifying engineering and IT solutions for E&U companies.Supplier Quality/Validation Engineer for a Class III Medical Device Manufacturer - Minneapolis, MNApril 2007 to June 2009 Show less

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  Cognizant Technology Solutions

  Nov 2012 - Jan 2022

  LS Compliance Lead - QE&A

  Global Pharmaceutical Client – Role: Program LeadManaging the overall delivery of the Quality Records Team that executes GxP processes such as Change Management, CAPA Management and Deviation Management.Global Pharmaceutical Client – Role: IT Audit and Compliance ConsultantThis role includes providing end to end audit support for external (regulatory and SOX) and internal audits for the IT organization. In addition, supporting the IT organization with multiple compliance activities (including but not limited to CAPA management, vendor management, deviation management etc.)Global Pharmaceutical Client – Role: Project Quality ManagerPrimary Software Quality Assurance lead for implementation of GxP and non-GxP systems. Show less

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  EY

  Jan 2022 - now

  Advising clients on their risk posture and help build solutions to mitigate/address risks.

  • Sr. Manager - Risk Consulting

    Aug 2024 - now

  • Business Consulting Manager - Technology Risk

    Jan 2022 - Aug 2024