SADASIVAM M
QA Manager
Chennai
Summary
- 15 Years of Professional experience in practicing Software Quality Assurance, ISO 13485:2016 for Medical Devices, Agile, ISO 9001, CAPA, ISO 62304, CMMI V2.0
- Successful execution of customer audits (Becton Dickinson, Baxter, Roche, Siemens and Abbott)
- Proven effective closure of customer audit findings and customer rated excellent in subsequent audit (Becton Dickinson)
- Successful execution of notified body audits (BSI) Involved in Quality Agreement review (Becton Dickinson, Baxter, Roche) Involved in Customer Supplier Audit Questionnaires preparation (J&J, Abbott and ADI)
- Lead the Medical Initiatives such as MDR, internal Audit tool, Customer CAPA tool
- Lead the critical account for SLA improvement
- Successful completion of Unilever IT General control, Service Management and Access control audits
- Successful completion of Microsoft Azure Migration Audit Willingness to learn, effective communication and leads the team
Overview
18
18
years of professional experience
6
6
Certifications
Work History
Senior Process Consultant
Infosys Limited
12.2021 - Current
- Lead the critical account for SLA compliance improvement
- Projects preparation for CMMI V2.0 journey
- Proven Agile implementation to Carlsberg program
- Monthly Senior Management report preparation with customer feedback, audit assessment trend, IQA CAPA status
- Conduct QMS training
- ISO 9001, CMMI v2.0 certification audit preparation of projects
- Preparations of projects for ITGC Customer audits and Azure Migration audit certification (Microsoft certification)
- Lean implemented for retail client Unilever
- Performed Internal Data Privacy audits
- Achievements: Appreciated by Delivery Executive with award for key contribution on zero non-conformances in external audit
- Received star awards for Microsoft Azure migration audit without any non-conformances and Avon project facilitation.
Medical Devices Quality Manager
HCL Technologies
10.2018 - 12.2021
- Lead the team for Medical Initiatives such as Medical Device Regulatory Initiative, CAPA Tool and Internal Audit Tool
- ISO 13485:2016 Certification audit preparation of projects and support functions (New site inclusion)
- Involved in Medical Quality Policy definition
- Preparations of projects and support functions for Customer audits
- Internal Quality Audit scheduling and tracking the projects and support functions
- Involved in Supplier audit questionnaire preparation
- Customer Quality Agreement review
- Management Representative slide preparation and tracking the action items for closure
- Heads the overall CAPA activity and ensure customer CAPA are tracked and closed appropriately
- Conducted Medical QMS and Good Documentation Practices Trainings
- Monthly Senior Management report preparation with customer feedback, PCI trend, Customer CAPA and IQA CAPA status
- Involved in CMMi V2.0 services gap analysis, updation of artifacts
- Prepared Medical projects for the checkpoint review and Final appraisal
- No major issues are identified by Assessment team members
- Well appreciated by top management on project preparation
- Achievements: Appreciated by senior executives for key contribution for zero non-conformances in external audit, no major non-Conformances in Customer audit, on-time completion of initiative and included in Medical QMS
- CMMi V2.0 implementation in Medical with no major issues appreciated by Top management
- Received Outstanding rating for the contribution.
Quality Lead
HCL Technologies
06.2012 - 07.2016
- Responsible for CMMI implementation for the CODC account, played the critical role in successful completion of CMMI Final appraisals fulfilled the HCL Business goal of CMMI certification with improvement in productivity and quality of deliverable
- Creating and enforcing quality culture in project teams through training, auditing and driving continuous to address the process gaps
- Involved in PIID (Process Implementation Indicator Description) collection and part of appraisal interviews conducted by KPMG
- Involved in ISO audit preparation and conduct monthly PCI audit
- Achievement: Appreciated by senior executives with snap award for key contribution in CMMI Assessment.
Lead executive Quality
Aricent Technologies
06.2008 - 05.2012
- Responsible for accomplishing the ISO 9001, CMMI certification and involved in process improvement initiatives to improve customer satisfaction
- Part of test case improvement initiative, test case automation improvement
- Compliance review of project as per ISO 9001 process
- Participated in senior management review and present the quality performance measure for the projects and track the action items for closure
- Conducted QMS, metrics and configuration management training.
Quality Engineer
HTC Global services
04.2006 - 05.2008
- Responsible for audits, facilitation and training to the delivery team
- Compliance review of project as per ISO 9001 process
- Perform deliverable audit before release to customer
- Ensure that the QMS processes are implemented consistently across teams
- Analyzing project performance through process and data analysis
- Analyzing and compiling root cause analysis for the project and take appropriate preventive action
- Conducted QMS training.
Education
MBA -
Madras university
01.2004 - 2006.04
BE - Mechanical
Madras University
01.1999 - 2002.04
Skills
ISO 13485, CAPA, Notified body audit, internal audit
CMMI V20, Scrum Agile
Certification
Certified Internal Auditor ISO 13485:2016
Timeline
Senior Process Consultant
Infosys Limited
12.2021 - Current
Medical Devices Quality Manager
HCL Technologies
10.2018 - 12.2021
Quality Lead
HCL Technologies
06.2012 - 07.2016
Lead executive Quality
Aricent Technologies
06.2008 - 05.2012
Quality Engineer
HTC Global services
04.2006 - 05.2008
MBA -
Madras university
01.2004 - 2006.04
BE - Mechanical
Madras University
01.1999 - 2002.04
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