Philippe D. Email & Phone Number

France

Neuchâtel, Suisse

Overall quality assurance leadership in the management of direct supplier and external manufacturers engaged in the production of Ethicon products ( Biosurgery and Gynecare ). Deployment of the Source Quality Management strategies, programs, initiatives, processes and systems for suppliers of the Ethicon supply chain.Provide business support ( NC, CAPA ).Lead, develop and implement supplier/purchasing controls.Manage Supplier Quality Agreements.Develop Quality Risk Management process for supplier-related activities.Monitor and analyse supplier performance metrics, identify areas of opportunities.Drive resolution of supplier quality issues and risk control process.Lead component qualification process.Supplier change control management.Support supplier audits.Complementary activities• Certified lead auditor as part of site internal audit program (compliance audits with FDA 21CFR part 820, EU ISO 13485-2016, Japan MHLW No. 169 Ordinance, ANVISA, Australian TGA, Health Canada). • Support external audits: front room and back room core team member for MDSAP certification audits and unannounced audits.• Subject Matter Expert for equipment and process validation including CSV (trained ISPE GAMP 5, EU annex 11 and FDA 21CFR part 11).• Team leader of CARE group (Customer Associate Responsibilities and Education) which provides education to associates and customers on products manufactured on the site:o Organization of training events for customers in collaboration with Marketing and Sales : 3 to 4 events per year ( pharmacist and surgeons from Italy, France, DACH, Middle east countries, Baltic countries ).o technical workshop for local associates

Neuchatel, Suisse

• MDR implementation (2018 –2019)Coordination of a multi-disciplinary team to drive changes to manufacturing processes needed to meet new regulation requirements (UDI, labeling, IFU, implant card).- Upgrade of manufacturing lines to implement the new MDR requirements: capture VOC, define User Requirement Specifications, lead feasibility studies and initiate process validations ( IQ, CSV, OQ, PQ ).- Support automation and technology transfer related to the duplication and deployment of manufacturing line to Puerto Rico site.• Secure production capacity (2017 – 2018)- Development and implementation of a new dehumidification unit for hemostats manufacturing line.- Lead equipment and process validations (URS, FAT, SAT, IQ, CSV, OQ, PQ)- Supervise clean room extension and facilities validations.This project secured Neuchatel manufacturing capacity and protected locally + M$ 300 in sales.• New automated production line qualification, change management and production ramp-up (2014 – 2017)- Coordination of a multi-disciplinary and international team (R&D, Design Quality, Regulatory Affairs, Packaging, Labeling, Stability, Sterilization, Toxicology) to support design changes required for process automation.- New sterile barrier material qualification.- Conduct process development, DOE, OQ and PQ qualifications.- Lead Design Reviews, Design Verification, Design Validation and Design Transfer activities. Updates to Design Requirement Matrix and Design History Files- Support Regulatory Affairs for file submissions to FDA and EU notified body (BSI).Project was successfully completed with the following benefits for the site:Cycle time reduction: from 3 production shifts to 1 shiftYearly production costs reduced by 1.2 M$ with material savings and head count optimization.Full conversion of product codes in scope and expected performances achieved.

Neuchatel, Suisse

•New automated line acceptance, Lean green belt (2012 – 2014)- Supervise new line construction at supplier site (Germany). Supplier monitoring and - Conduct Factory acceptance tests (FAT), delivery, re-assembly and Site Acceptance Tests (SAT).- Conduct IQ including CSV. Equipment performances meet targeted speed of 200 parts/min. - Lean green belt certification: implementation of lean flow for existing automatic secondary packaging line ( cartoner, cellophane overwrapper ,and palletizer). Benefit for the site at the end of the certification: full line operated with 3 operators against 6 previously.- Led local implementation for Chinese Labeling update linked to CFDA Order 650 change. This change affected all levels of packaging for product codes sold to China.•Design of a fully automated high-speed packaging line for hemostats (2010 – 2011)- Apply principles of DFM : simplify design, process capability analysis, mistake proof, harmonize product variants, design for automation.- Capture Voice of the Customer, define User Requirement Specifications, conduct feasibility studies and proof of principle trials with a selection of suppliers.- Build CAPEX justification and ROI calculation.- Lead process optimization of product dehumidification process to meet capacity and future packaging process constraints.- Supervise clean room extension construction to accommodate new equipment.

Région De Grenoble, France

Team management: leadership of 1engineer and 3 techniciansAccountable for assembly processes development and qualification for new products.- Die bonding,- flip chip bonding / underfilling, - Wire bonding (aluminum wedge, gold ball)- Wafer dicing- Soldering- Fiber optic coupling, surface treatment ( corona, plasma) - Hermetic sealingTechnical referent for feasibility studies in packaging assembly services.

Région De Grenoble, France

- manufacturing support : ensure continuity and quality of production, day to day issue resolution, training.- Process Development ( DoE) and process validations- Drive continuous improvement: implementation of statistical process control (SPC), Measurement System analysis (MSA) and Gage R&R.

Dea, Électronique

Ingénieur, Science Des Matériaux