Rakesh Kumar
Global Supplier Quality Management - Medical Devices | ISO 13485 | FDA | ISO 27001 | CDSCO
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About
Results-driven Quality & Development Leader with 17+ years of progressive experience in the medical device, consumer electronics, lighting, and automotive sectors. Currently driving APAC supplier quality strategy at Philips Healthcare, with deep expertise in ISO 13485, APQP/PPAP, supplier audits, risk management, Change Management and regulatory compliance. Certified ISO 13485 & ISO 27001 Lead Auditor, Six Sigma Green Belt, and IATF 16949 Lead Auditor.
Proven track record of building high-performing supplier quality systems, reducing defects, and ensuring market-ready compliance, Supplier development and ramp up across global supply chains.
Experience
Supplier Quality Manager — Markets APAC - Philips India
(2022-04)
- Drive APAC regional strategic planning and management of supplier development activities for medical devices and healthcare products. Manage and guide the daily operations, development, and overall performance of the Supplier Quality team.
- Lead global ISO 13485 QMS audits and develop supplier QMS improvement plans across the APAC supply base.
- Developing alternate sourcing and risk mitigation. Lead Supplier development plan and review launches and release milestones
- Manage Supplier-Initiated Change Requests (SICR) globally, ensuring regulatory traceability and market compliance.
- Act as the technical expert during audits to guarantee full compliance with safety laws and FDA guidelines
- Managing CAPA for business and SCARS related to 3rd party products and Driving Audit program based on the risk assessment.
- Maintains APAC quality standards, ensures local regulatory compliance, and resolves audit findings promptly.
- Execute product risk assessments and market clearance processes for both medical and non-medical products across ISC markets.
- Oversee APQP/PPAP projects, supplier onboarding assessments, capability analysis, and new product development partnerships.
- Manage the global approved supplier list, track performance metrics, and handle contract agreements across all corporate sites.
- Maintain KPI dashboards at regional level and drive supplier performance improvement plans.
- Create tracking dashboards, audit systems, and performance scorecards to continuously improve supplier standards
- Develop and govern the Supplier Maturity Grid to systematically upgrade supplier QMS and process excellence.
- Drive Improvement actions with supplier's based on risk assessment.
- Won Q3 Star Award for leading Product Risk Assessment in ISC Market.
- Framed regulatory requirements matrix for medical/non-medical products for ISC third-party suppliers.
Supplier Quality Specialist - Stryker Global Technology Center
(2021-09 - 2022-04)
- Led centralization and standardization of the Approved Supplier List (ASL) across all global markets.
- Supported supplier qualification activities and maintained QMS compliance per ISO 13485 requirements.
- Collaborated with global procurement and cross-functional teams to ensure supplier readiness for product launches.
Assistant Manager Supplier Development - Tenneco Powertrain
(2017-04 - 2021-09)
- Led supplier development and APQP/PPAP activities for powertrain component suppliers across the supply base.
- Successfully launched DLC Piston Pin manufacturing as part of BS6 emission standards upgrade — a critical regulatory milestone.
- Conducted IATF 16949 and VDA 6.3 process audits; implemented CQI-9 special process audit protocols.
- Managed supplier risk assessments, performance scorecards, and corrective action (8D/CAPA) programs.
AM— QA - Foxconn Technology Group (RSMIPL)
(2016-06 - 2017-04)
- Managed incoming quality, in-process quality control, and supplier quality for electronics manufacturing.
- Drove supplier audits and corrective action plans to ensure component quality compliance.
Lead SQA & Vendor Development - Philips India Limited
(2009-09 - 2016-06)
- Led a Six Sigma DMAIC project (SSGB) that reduced PCB rejection rates by 50% at co-manufacturers.
- Led the greenfield setup and qualification of a new PCB supplier for Philips Lighting, from sourcing to full launch.
- Drove vendor development initiatives across the component supply base for consumer electronics and lighting divisions.
Education
B.Tech - Industrial Engineering - Punjab Technical University
Diploma - Mechanical Engineering - Govt. Poly Tech, Mohali
Adv. Diploma - Industrial Engg. & Management - Punjab Technical University

