Gianluca Tordi, MsC, EMBA
Founder and Managing Director at TS Quality & Engineering- Claim this Profile
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Italiano Native or bilingual proficiency
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Inglese Full professional proficiency
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Tedesco Elementary proficiency
Topline Score
Bio
Sanjoy Choudhuri
I know Gianluca over nearly the last 4 years. In early 2015 Gianluca and I joined Depuy Synthes R&D as consultants. While I was in the Nailing NPD team, Gianluca was in the Plates & Screws NPD team, working on the design and development of a trauma plating system for the upper anatomy. Gianluca has an extremely flexible mind which is very much essential in the R&D of today considering the various kind of work, which are typically encountered by R&D engineers of today. Gianluca is a nice & friendly person and has a great sense of humour.It was a great pleasure discussing with him on technical matters related to projects, products, technology, or the orthopaedic industry in general.
Sanjoy Choudhuri
I know Gianluca over nearly the last 4 years. In early 2015 Gianluca and I joined Depuy Synthes R&D as consultants. While I was in the Nailing NPD team, Gianluca was in the Plates & Screws NPD team, working on the design and development of a trauma plating system for the upper anatomy. Gianluca has an extremely flexible mind which is very much essential in the R&D of today considering the various kind of work, which are typically encountered by R&D engineers of today. Gianluca is a nice & friendly person and has a great sense of humour.It was a great pleasure discussing with him on technical matters related to projects, products, technology, or the orthopaedic industry in general.
Sanjoy Choudhuri
I know Gianluca over nearly the last 4 years. In early 2015 Gianluca and I joined Depuy Synthes R&D as consultants. While I was in the Nailing NPD team, Gianluca was in the Plates & Screws NPD team, working on the design and development of a trauma plating system for the upper anatomy. Gianluca has an extremely flexible mind which is very much essential in the R&D of today considering the various kind of work, which are typically encountered by R&D engineers of today. Gianluca is a nice & friendly person and has a great sense of humour.It was a great pleasure discussing with him on technical matters related to projects, products, technology, or the orthopaedic industry in general.
Sanjoy Choudhuri
I know Gianluca over nearly the last 4 years. In early 2015 Gianluca and I joined Depuy Synthes R&D as consultants. While I was in the Nailing NPD team, Gianluca was in the Plates & Screws NPD team, working on the design and development of a trauma plating system for the upper anatomy. Gianluca has an extremely flexible mind which is very much essential in the R&D of today considering the various kind of work, which are typically encountered by R&D engineers of today. Gianluca is a nice & friendly person and has a great sense of humour.It was a great pleasure discussing with him on technical matters related to projects, products, technology, or the orthopaedic industry in general.
Credentials
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ISO 13485:2016 Internal Auditor Certification
MDPC -
TS Q&E - ISO 13485:2016 Certification - Medical Device Quality Management System
ITALCERT S.r.l.
Experience
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TS Quality & Engineering
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Switzerland
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Medical Equipment Manufacturing
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1 - 100 Employee
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Founder and Managing Director
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Jan 2012 - Present
TS Quality & Engineering is a ISO 13485 certified company which offers solutions aimed at facilitating and speeding up the design, validation and quality control process for medical device field. We can follow the development of a new product at all stages, from design and engineering to documentation part. We can follow the procedures for testing, verification and validation. We can create required compliant documentation to register your device in highly regulated markets. We have a network of specialist and SMEs that will be able to provide specilized support. We can guarantee a quick, focused and highly qualified service. Design and Development Medical Device: Orthopaedics, Traumatology, Neuro, Cardio, Surgical instruments Class I, Class II, Class III. Regulatory Support: New MDR 2017/745 support, DHF, Tech File, Clinical Evaluation, Design Dossier, 510k, Risk file, Remediation project. Quality Support: ISO 13485 Certification Support, Internal and External Auditing, SOP and Process Gap Analysis. Process Validation: URS, VMP, DQ/IQ/OQ/PQ, GAMP5, FAT, SAT, FS, HDS, SDS. Training on Regulatory and Quality Topics: NEW MDR 2017/745, CAPA, PMS, Tech File, ISO 13485 Internal Auditor Show less
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TechBricks
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Italy
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Technology, Information and Internet
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1 - 100 Employee
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Entrepreneur in Residence
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Jul 2021 - Present
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Bayer
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Chemical Manufacturing
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700 & Above Employee
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Senior Design Quality Engineer Consultant
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Sep 2021 - Sep 2022
DHF Remediation and Risk Management for Substance-Based Class III Medical Devices DHF Remediation and Risk Management for Substance-Based Class III Medical Devices
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medmix
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Switzerland
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Medical Device
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200 - 300 Employee
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Project Manager LCM
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Mar 2020 - Jun 2022
Coordination activites for pen injectors new projects and LCM Coordination activites for pen injectors new projects and LCM
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CSL
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Australia
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Biotechnology Research
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700 & Above Employee
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Senior Quality and Design Control Remediation Lead Consultant
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Nov 2018 - Dec 2021
Design Control Remediation - Combination Products: Pre-filled Syringes, Mix2vials, Injection Pumps - Legacy Product Remediation - New Product Development Process - Risk Management Remediation - Design Quality - Compliance - HFE Process - Hazard Analysis Design Control Remediation - Combination Products: Pre-filled Syringes, Mix2vials, Injection Pumps - Legacy Product Remediation - New Product Development Process - Risk Management Remediation - Design Quality - Compliance - HFE Process - Hazard Analysis
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Philips
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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E2E Q&R
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Mar 2019 - Feb 2021
Taking care of keeping continuous compliance of the Philips Quality Management System for product development lifecycle of medical devices I2M (Idea to Market) and (PDLM) with EU MDR, ISO 13485:2016, 21 CFR 820 when transitioning from standard QMS to PEPF and ARIS BPM. Taking care of keeping continuous compliance of the Philips Quality Management System for product development lifecycle of medical devices I2M (Idea to Market) and (PDLM) with EU MDR, ISO 13485:2016, 21 CFR 820 when transitioning from standard QMS to PEPF and ARIS BPM.
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Medical Device Technical Expert
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Dec 2016 - Mar 2019
Combination Device Products: Needle Safety Device, Pre-Filled Syringes, Autoinjectors NPD Process - DHF - 21 CFR 820.30 - Requirement Platforming - Design Control - V&V - ISO 11608 - ISO 11040 - IEC 62366 - HFE Combination Device Products: Needle Safety Device, Pre-Filled Syringes, Autoinjectors NPD Process - DHF - 21 CFR 820.30 - Requirement Platforming - Design Control - V&V - ISO 11608 - ISO 11040 - IEC 62366 - HFE
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DePuy Synthes
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United States
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Medical Device
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700 & Above Employee
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Senior Product Development Engineer - Plates & Screws - Upper Extremities
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Jun 2015 - Dec 2016
Ostosynthesis Plates and Instruments - Upper Extremities - Product Development - New NPD - Design History File - Design & Engineering - Prototyping - Validation & Verification - FEM - Patent and Inventions Ostosynthesis Plates and Instruments - Upper Extremities - Product Development - New NPD - Design History File - Design & Engineering - Prototyping - Validation & Verification - FEM - Patent and Inventions
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Zimmer Biomet
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Senior Product Development Engineer
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Dec 2014 - Sep 2015
Trauma and Intramedullary devices - Product Development - Risk File Remediation - DHF Remediation - PMS Support - ISO 14971 Trauma and Intramedullary devices - Product Development - Risk File Remediation - DHF Remediation - PMS Support - ISO 14971
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Johnson & Johnson
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United States
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Hospitals and Health Care
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700 & Above Employee
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PDE - P&S - VA Hand - V&V Methods - DCRM - Consultant Engineer
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Mar 2014 - Dec 2014
GRQP Global Remediation Quality Program - Risk Management Remediation - Verification and Validation Design History Files - New Product Development Support GRQP Global Remediation Quality Program - Risk Management Remediation - Verification and Validation Design History Files - New Product Development Support
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Lima Corporate
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Italy
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Medical Equipment Manufacturing
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700 & Above Employee
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R&D Engineer ; QARA Engineer
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Oct 2009 - Mar 2014
Design and Development of Osteosynthesis Device and Instruments - Mechanical Engineering - Product Development - Technical Files - Clinical Evaluation - CE Marking - Risk Files - Process Validation - IQ/OQ/PQ - VMP - ISO 13485 Quality Management System - ISO 14644 - ISO 14155 Design and Development of Osteosynthesis Device and Instruments - Mechanical Engineering - Product Development - Technical Files - Clinical Evaluation - CE Marking - Risk Files - Process Validation - IQ/OQ/PQ - VMP - ISO 13485 Quality Management System - ISO 14644 - ISO 14155
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Hit Medica a Lima Company
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Italy
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Medical Equipment Manufacturing
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1 - 100 Employee
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R&D Engineer
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Oct 2007 - Dec 2011
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Education
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2011 - 2011
Esame di Stato
Ingegneria Industriale, Ingegneria -
2003 - 2010
Università di Bologna / University of Bologna
Ingegnere Biomedico -
2021 - 2023
Quantic School of Business and Technology
Executive MBA, Business Administration, Management and Operations
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