Results-driven Technical Consultant with expertise in quality management and a proven track record of leading cross-functional teams to achieve a 95% on-time project delivery rate. Proficient in ISO 9001, ISO 13485, ISO 27001, ISO 27701 & ISO 42001 standards and Agile methodologies. Demonstrates strong project management skills and effective leadership to ensure compliance while promoting team development. Specializes in risk management and excels at fostering collaboration and communication with stakeholders to enhance project outcomes.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Technical Consultant
Maruthi Quality Management Services
Bangalore
10.2017 - Current
Managed high-stakes project deliveries to establish a comprehensive Quality Management System, ensuring compliance with ISO/IEC standards across multiple projects.
Formulated thorough timelines and resource distribution strategies for projects, achieving a consistent 95% on-time completion rate.
Ensured compliance with regulatory requirements from US-FDA, EU-MDR, India, Australia-TGA and ISO/IEC standards through effective quality assurance.
Enabled team success through effective cross-functional collaboration.
Supervised project lifecycles totaling more than $2 million, ensuring comprehensive oversight from start to finish.
Contributed to creation of work breakdown structure, schedule network diagram and activity attributes.
Created a supportive environment fostering team skills and career development.
Effectively oversaw stakeholder interactions to meet project objectives.
Achieved faster delivery times by leading project teams in Agile transformation.
Implemented comprehensive SOPs to enhance efficiency in quality processes.
Identified non-conformities during internal audits and suggested corrective actions.
Partnered with regulatory teams to apply various standards, guaranteeing compliance of organizational assets.
Certified in GDPR and CE Marking implementation as per EU-MDR from BSI
Accomplishments
Achieved a 98% project success rate, delivering projects on time, within scope, and on budget, with a high level of stakeholder satisfaction.
Ensured product reliability and supportability through telemetry, performance monitoring, and a proactive approach to customer feedback and root cause analysis.
Reduced customer-reported issues through improved root cause analysis and feedback loops, increasing customer satisfaction.
Successfully led organizations through the ISO standards certification process, ensuring full compliance with applicable quality management standards.
References
References available on request
Timeline
Technical Consultant
Maruthi Quality Management Services
10.2017 - Current
Senior Quality Engineer – Business Suite Test Center
SAP Labs India Pvt Ltd
07.2006 - 05.2011
Software Engineer – Verification of Multi-function Display of Boeing 777
Silver Software Pvt. Ltd.
07.2005 - 06.2006
Project Management Professional (PMP) – Project Management Institute (PMI)
Certified Quality Auditor (CQA) – American Society for Quality (ASQ)
ISO 13485:2016 (Medical Devices: Quality Management Systems) Lead Auditor Certification
ISO/IEC 27001:2013 (Information Security Management Systems) Lead Auditor Certification
ISO 27702:2019 (Privacy Information Management Systems) Lead Auditor Certification