Quality Assurance Associate Director

Saravanan Srini MS, MBA PMP

Email: *********.*****@*****.*** Phone: 409-***-****

https://www.linkedin.com/in/saravanan-srinivasan-2ba4b712/ Professional Profile:

Strong thought leader in healthcare and life sciences, with recognized achievements in strategic planning, quality systems transformation, healthcare technology and operations.

Dynamic professional with 12+ years of experience in leading strategic initiatives to address challenges around constantly evolving regulations within the Medical Devices, Pharmaceutical and Automotive industries.

Strategic thinker with a creative approach to problem solving; astute in identifying opportunities for improvement, with the vision to help cross-functional teams to develop and implement successful action plans.

Experienced in forging alliances, building relationships and creating high-performance teams. Core Competencies & Strengths:

QMS transformation New Products Design Transfer Strategic Planning Lean Six sigma Project Management Supplier Development CAPA & Complaint Handling Quality Assurance Enabling Culture Change Operations Management Risk Remediation Regulatory Compliance Change Management Audit (ISO 9001/ISO 13485/TUV)

Professional Experience:

Manager, Advisory -Life Sciences Q & R, KPMG Sept 2022- Sept 2023

- Planned and executed the divestiture activities for Q&R at a Top 20 Pharma client including ensuring supply continuity by establishing playbooks & project management for regulatory and quality systems transition.

- Designed future state process flow and facilitated the development of data model landscape to support real time batch processing and EBR creation at a top 5 Pharmaceutical company.

- Provided thought leadership on recent trends in FDA audits and developed quality offering for the trend.

- Led proposal development, targeted business development activities and defined service offerings for the transformation of Quality systems at Pharmaceutical and Medical Device clients.

- Developed quality process accelerators and templates for ISO 13485 audit assessments and systems validation.

Q & R Lead/ Ad- Interim Site Quality Director, Philips Medical Systems Nov 2020– Aug 2022 Product Quality Eng Lead, Philips Medical Systems Oct 2013 – Nov 2020

- Led and coached the business quality team in Latham in a highly matrixed organization and provided leadership support for all activities related to QMS elements (CAPA, complaints, deviations, NC, audits), regulatory and design quality.

- Led Management Review and CAPA Review Board for Philips Medical Systems in Latham, NY.

- Led a cross functional team to perform FDA readiness assessments in Latham site across various QMS elements. Led the prevention activities to reduce potential future audit nonconformities.

- Hosted and led compliance audits (front room /backroom operations) for the Latham and GNV site operations including external audits (ASME, TUV and Dekra). Initiated follow up efforts to ensure compliance with company policies and standards (ISO9001:2015/ISO 13485:2016).

- Led the Q&R elements of a multi-million-dollar project in the transfer of MR RF coil production from Gainesville (FL, USA) to Pune (India). Transitioned the products from MDD to EU MDR status.

- Proactively led a cross functional team in the developing framework for an E2E Product performance management.

- Established strong relationships with internal and external stakeholders (customers) and eliminated silos to ensure effective communication and resolution of customer complaints, CAPA and SCARs.

- Reduced non-conformances and rectified regulatory compliance gaps in product assemblies to ensure 100% RSL compliance.

Saravanan Srini MS, MBA PMP

Email: *********.*****@*****.*** Phone: 409-***-**** https://www.linkedin.com/in/saravanan-srinivasan-2ba4b712/

- Lead APQP and validation activities for design transfer of three NPI MRI magnets from prototype to production. Achieved savings of $250,000 per year by improving transportation efficiency.

- Facilitated a kaizen with Site Quality lead, incoming quality, and supplier quality teams to eliminate unnecessary inspections and reduced the time spent on incoming inspections by 30%.

Product Quality Engineer- AT Quality, Cummins- RMEP Jan 2011 – Oct 2013

- Developed and established plant wide layered process audit program at a supplier plant and created a visual tracking system to track the completion and effectiveness of the audit. Increased audit compliance rate by 40% and reduced PPM from 500PPM to 50PPM.

- Managed the internal process audit program, developed a visual management system to identify repeat issues and led the corrective action implementation. Established a plant wide Level 3 (Exec level) process audits.

- Saved $500k in the fiscal year by leading six sigma projects and eliminated damaged defects / high angle failures by 60%.

- Led a team of Quality technicians to resolve process variations in critical torque units and ensured a Cpk >1.67

- Reduced the lead-time to resolve Corrective Action Requests (CARs) by 75% by leading cross functional teams to address customer complaints utilizing problem solving techniques (8D problem solving).

Quality Project/ Packaging Specialist at Igloo Products Corp Feb 2010 – Jan 2011

- Saved $600,000 in the fiscal year by optimizing carton sizes and eliminating usage of excess material.

- Developed a cell layout by collaborating and facilitating Kaizen events with Sr. Industrial Engineers resulting in a 50% scrap reduction, achieving a savings of $200,000in the fiscal year.

- Standardized the process of loading products in a container and warehouse by determining the pallet pattern configurations and optimizing space to load most products per container/warehouse in an efficient way. Educational Qualifications:

MBA (Executive), SUNY Albany Sep 2015 – Dec 2017 Thesis: Impact of MRI patient and provider education on safety issues, “First Time Right” percentage and patient throughput in hospitals. This was submitted to enhance the Philips patient experience app – “Ellie’s MRI Journey”

M.S. Industrial Engineering, University of Houston Aug 2007 – Dec 2009

B.Tech. Mechanical Engineering, SASTRA University Aug 2002 – May 2006 Certifications:

ISO 13485:2016 Lead Auditor Training Course Sep 2023

GCP: ICH Good Clinical Practice (ICH-GCP) Aug 2023

Trackwise Digital (Platform, Complaints & EQMS) July 2023

ISO 13485: Quality Management System for Medical Devices – certified by Philips Medical Systems Feb 2022

21CFR Part 820- cGMP for Medical Devices – certified by BioPharma Institute Feb 2022

Project Management Professional (PMP) certified by PMI Dec 2020

Certified SAFE 5 Scrum master May 2020

Six Sigma Green belt – certified by Cummins Inc. Aug 2012

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