Sourabh Dharmadhikari
Exposure in Medical Device and Automotive sectors | ISO 13485 | FDA | ISO 14971 | IATF 16949
- Role
- Senior Quality Engineer at Stryker
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
About Sourabh Dharmadhikari
As an experienced Quality Engineer with over 10 years of expertise in the Automotive and…
Experience
Senior Quality Engineer
Sep 2022 — Present · Gurugram, IN
Working on SICR (Supplier initiated change notice) to solve the supplier issues during manufacturing.• Suppliers PPAP review and execution during new development as well as change process to meet ourstandards.• Working on CAF (Change assessment form) and GIA (Global impact assessment) to meet the deliverables asper the change.• Interacting with various stakeholders and help team to create a detailed requirement document.• Support and approve the commissioning, IQ, OQ, PQ, validation, and operating documentationin Equipment qualification along with CSV activities covered through Velgenesis 4.1.• Verification of Supplier Process audits and supplier evaluation experience as per the standard.• Working on NC/CAPA to solve the medical devices issues.• Create and process on ECN/CN, process routers, drawing updates and other written documentation.• Ensuring DHF and DMR compliance in line with the regulatory requirements.• Assist in inspection, approval and testing of incoming materials and components.• Manage Verification and Validation activities.• Working on Product Shelf life for cost saving purpose.• Maintenance of the Approved Supplier List (ASL) in conjunction with global sourcing, supplier controlsand audit functions.• Supporting Stryker Neurovascular Site with Access, Embolization, Thrombectomy and Angioplasty andStenting products.• Adhere to Quality system procedures, ISO 13485, 21CFR820 and ISO 14971:2019.• Basic understanding of EUMDR, 510K.
Skills
- Supplier Development
- 8d Problem Solving
- 5s
- Manufacturing
- Machining
- Six Sigma
- Root Cause Analysis
- Factory
- Vda
- Automotive
- 7 Qc Tools
- Advanced Product Quality Planning (Apqp)
- Supplier Quality
- Product Development
- Msa
- Incoming Inspection
- Continuous Improvement
- Iso/Ts 16949
- Kaizen
- Production Part Approval Process (Ppap)
- Supplier Negotiation
- Lean Manufacturing
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