marc-antoine durieux-trouilleton

Work as volunteer reinforcement of Gendarmerie in all police duties (Highway patrol, territorial surveillance and intervention…)

Worked in all the production line posts, and in the quality service

* Project : Dolphin circadian cycle and differences with human genome * Sequencing of circadian genes and alignment with human * Skills : Bioinformatics, PCR, Ugene, polyphen2 and mega5 software

* Quality in New Product Development * People Management experience ( 2 senior Engineers (contractors), a Quality Technician and an Engineer II) * Risk management: Risk management plan, Design FMEA development, Risk benefit analysis support, Complaints analysis * Design input/output/user needs definition, VOC * Product/process mapping * Test method validation/gage R&R development * Design verification/validation plan * Statistical analysis/six sigmas for validation/verification * Design transfer to production * Design change control * Supplier process validation/verification * Combination product compliance (21 CFR part 4, 820/210/211)

* Single entity, drug/device Combination product compliance (21 CFR part 4, 21 CFR part 210/211, ICH guidelines Q1A to Q1F): * Process improvment * Calculation of yield * Sample size rational * Stability program * Sample retention program * OOS management * Temperature mapping * Testing and approval/release

* QE engineer in medical device industry, ISO Class 8 cleanroom: * Quality project management * Non conformities management (conducting Material Review Board meeting, NCs tracking and investigation and corrective actions coordination) * Non conform products disposition and root cause investigation * New product/Process validation, (IQ, OQ, PQ, PPQ), Protocol/report development * GMP, ISO13485, FDA 21 CFR part 820 application * Audit backroom support * Quality standard documents, inspection check list and manufacturing procedure implementation * Use of statistical Tools for measurement and process analysis: Capability, Gage R&R, sampling plan (Use of Minitab software). * Root cause analysis/failure investigations and risk management (Process FMEA). * Proactive review of processes and norme to identify any improvement opportunities

* Quality in New Product Development * Management of Design Quality Engineering group (New Product Development and Lifecycle Management) * Risk management: Risk management plan, Design/Application/Process FMEA development, Risk benefit analysis support, Complaints analysis * Design input/output/user needs definition, VOC * Product/process mapping * Test method validation/gage R&R development * Design verification/validation plan * Statistical analysis/six sigmas for validation/verification * Design transfer to production * Design change control * Supplier process validation/verification * Combination product compliance (21 CFR part 4, 820/210/211)

* Quality in New Product Development * Risk management: * Risk management plan * Design FMEA development * Risk benefit analysis support * Complaints analysis * Design input/output/user needs definition * Product map * Test method validation/gage R&R development * Design verification/validation plan * Statistical analysis/six sigmas for validation/verification * Design transfer to production * Design change control * Supplier process validation/verification * Combination product compliance (21 CFR part 4, 820/210/211)

Activities and Societies: Staff in the association of Polytech'Clermont-Ferrand Gala