SR. Consultant

Expert : MDR/***, ISO *****:****, ISO 9001:2015, FDA 21 CFR part 820, QMS, Regulatory Affairs, Technical file, Auditing, QMS, Supplier Quality, Supply Chain Management, Logistic, Import & Distribution ;

Bruno Gomes

Paul Vouga 183

2074 Marin-Epagnier

Mobile 079*******

adi3e8@r.postjobfree.com

EXPERTISE

Standards US FDA 21 CFR part 820

ISO 13485:2016

MDR/745

ISO 9001:2015

Auditing ISO19011:2011

Risk Management: ISO 14971

Development of Quality plan for the organization

Regulatory affaires

Internal & External Audits

Technical Product file/ Annex I, II, VIII.

Legacy Review & Remediation

EXPERIENCE

Quality Agreement

SRM relationship with suppliers

Knowledge of GMP, GDP

Document Control

Lean Six Sigma Black Belt Project Management

Value Mapping

Process Improvement

Process Validation

5S

Investigation & CAPA

Training of suppliers

Supplier Quality Management

Change management

Sub-contracting

Sterilization process

Sub-contracting of medical devices

Inventory management

Logistics & Distribution

Supply Improvement

Relationship Management

Development of Training matrix

Dec 2019 –Dec 2020 Consultant UNISUR Import& Distribution of Medical Devices (start-up)

• Development of QMS as per the MDR/745, and ISO 13485-16 Standard

• Responsible for the overall establishment of management and continual improvement of the Quality Management System according to global regulatory requirements for medical device

• Communication with Swiss Medics Swiss regulations – pursuant to the Medical Devices Ordinance (MedDO; SR 812.213

• Evaluation, selection of the supplier and the supplier management

• Develop complaint handling process as per the requirement of MDR

• Assessments/audits/inspection by competent authority (EU documentation requirement)

• Assessment of transport conditions compliance

• Risks assessments and regulatory management

• Warehousing

May 2019 – 30 Nov 2019 SRM Project Manager for MDR implementation DepuySynthes

• Establish and Manage supplier relationship with the supplier to implement MDR

• Manage the new Process and Procedure for CE marking on the parts with Notified Body No

• Manage the new update of variance of the technical drawings from MDD to MDR

• Evaluate the feasibility of the technical requirements of the supplier to implement MDR

• Review with the supplier new update of variance of the technical drawings from MDD to MDR

• Review of Feasibility, Capability and Technical know-how of the supplier

• Interaction with the Manufacturing, Quality Engineers, and Purchasing to implement MDR

• Set meetings with the suppliers to resolve any issues

• Evaluate and Implement with the supplier the requirement of Form F-S448

• Approval of all the documents as per the requirement of MDR of all the stakeholders and the achieve

May 2018 – Nov 2018 Quality Manager Clestra SA (sub contract Biogen)

• Responsible to maintain Quality Management System

• Internal Audits of the installations of the clean rooms for the company Biogen

• Inspection of the Clean Room and monitor Non-conformances

• Control of the warehouse, Inspection and distribution of the product on site

• Development, verification, validation of the CTOP’s

• Document Control as per the Standard

• Submission of document to biogen for final QA acceptance

May 2017 – Dec 2017 Quality Specialist Medicareplus International U.K

• Quality and Regulatory affairs

• Implementation and management of the QMS compliant with current standard ISO 13485, European regulation;

• First interlocutor for MHRA, notified body, FDA, and customers audits;

• Owner of the incoming quality control processes; customer complaints handling processes

• Analyzed and interpreted regulations and/or standards,

• Management of non-conformities and corrective actions/preventive actions;

• Gap analysis for certification of ISO 13485-2012 to 2016

• Develop new product Technical file as per the requirement of MDR

• Technical support for product registration in different markets (USA, Canada and EU)

• Responsible for development, update technical files products for CE Mark approval (Class I and, IIA devices)

• Develop Risk management as per the ISO 14971:2012

• Internal Audit and Change Management

• Supporting external manufacturing of medical device (China)

Sept 2014 - March 2016 Quality Specialist BG Import & Distribution of Medical Devices

• Responsible for the QMS overall management and continual improvement

• Lead, develop, implement, maintain and improve the Quality System and Distribution

• Responsible for the quality oversight of the products distribution.

• Communication with Swiss Medic as regards to authorization of new products introduction and distribution

• Provide expertise in Logistics, Warehousing, and Distribution

June 2013 - June 2014 Consultant Supplier Quality Assurance Depuy Synthes

• Participated as consultant GRQP project (Global Remediation Quality Programme) – Supplier Quality Assurance

• Provided consultancy and guidance related to supplier quality assurance in Medical Devices as per the FDA 20 CFR 820, ISO 13485-2012, compliance requirement, as part of the Global Remediation Quality Programme for medical devices.

Analyzed and interpreted regulations and/or standards, applied them to product changes, and determined resulting course of actions.

• Legacy Review & Remediation of Suppliers Quality system

• Participated in audits program, Reviewed quality assurance agreement with suppliers

• Desktop Audit & Site Audit, new supplier quality agreement.

December 2012 - April 2013 Project Manager Lean Six Sigma Black Belt Semtech Corporation

• Lead and Manage Lean Six Sigma Project on three sites, USA, Canada, Neuchatel

• Effectively lead a team of Engineers on three sites and ensured that project objectives are met

• Developed effective strategies for the project which meet business goals

• Optimize processes to reduce waste and increase the productivity within the organization

January 2011 to December 2012 Sr. Manager Pesca and Mar Switzerland

• Managed Start-up company, built up global supply cold - chain in food industry

• Defined, supported of implemented Sourcing processes and strategies

• Lead strategic Sourcing & global Commodity Management

April 2008 - December 2011 Purchasing Manager RUAG Space

• Lead Procurement activities, reduced time required for purchase requisition approval from 1 week to 2 days,

• Relationship management, including KPI measurement and regular business reviews with the contracted Logistics Services Providers

• Analyzed and measured supplier quality performance (KPI)

• Implemented project SAP MM module, Ariba, P2P software’s

September 2007 – December 2007 Senior Buyer Petroplus Refinery Cressier

August 2006 – August 2007 Contract Buyer DePuy Synthes

• Lead procurement and outsourcings services

EDUCATION TRACK RECORD CONTINOUS LEARNING

2020 Webinar: Internal and external audit

2019 Webinar Explaining IVD Classification issues

2019 Webinar IVD Technical Documentation needed to support CE Marking Certification in Europe

2019 Webinar What are the new rules for invitro Diagnostic Industry with IVD 2017/746?

2019 Webinar preparation for the in Vitro Diagnostic Regulation IVD 2017/746

2018 Webinar: MDR, MDSAP

2017 Medical Device & IVD regulation, impact for MD manufacturers

2017 What are in Vitro Diagnostics (edma Diagnostics for health)

2017 Lead Auditor Course ISO 13484-2016 (BSI)

2016 Global Distribution Practice (GDP certification / Inspired Pharma)

2015 Investigation and CAPA / Pathwise / Copenague

2014 21 CFR 820… FDA Quality System Requirements and Industry Practice / ROME/certificate -AAMI

2012 - 2013 Lean Six Sigma Black Belt / Ariaq/ Switzerland

2004 ZD Goethe Institute (German language certificate) – Germany

1998 Diploma in supply Chain (Swiss certified Purchasing Manager – ex. ASAA / Procure.ch)

1998 International federation of purchasing and materiel management certificate – IFPM

1981 Analyst Programmer Diploma- Genève

1980 French Course “Ecole Theler” Sion / Valais

1979 Bachelor of Commerce /Economic, Accountancy- University of Bombay/ India

TRAINING IN COMPANIES

• Johnson & Johnson (various FDA’s Quality System Requirement (QSM Training)

• Global Remediation Quality Plan on Boarding

• SOP reduction, verification, validation

• The Elements of a Quality System, FDA Correction and Removal Report

• Failure Investigation Process and Problem-Solving Process

• Root cause Analysis Guidance Document, Failure Investigation Process and Problem-Solving Process

• Receipt of Product Complaint and Adverse Event Information

• Nonconforming Report Instruction, Nonconforming Materials Report – ICDS

• GRQP Process, Gap Analysis Guideline, GRQP Guideline for Trending of observations

• Escalation of Quality and Regulatory Issues – ICDS Significant Quality Issues; Internal Communication

• Regulatory Compliance Issues; Internal Communications – ICDS Field Action Process: Preliminary Risk

• Assessment, Health Hazard, Eval, Quality Review Board – ICDS, Purchasing Controls

• Regulatory Requirements Overview

LANGUAGES

English Mother tongue,

French High level

German Middle level (intensive course /Koln/Germany)

Portuguese Basic

SOFT SKILLS

Leadership, Communication, Teamwork, Problem Solving, Positive Attitude, Flexible, Decision Maker, People management, Ethical, Influencing others

COMPUTER KNOWLEDGE

COMPUTING: Ms Office, Ms Project, PowerPoint, Outlook

ERP: SAP, Ariba, / CAM / Mapix / JD.Edward / MRP

PROJECT MANAGEMENT

Sub-contracting project for DepuySynthes

Subcontracting project for development of new products (Ruag Space)

Start-Up project for Pesca and Mar

Lean Six Sigma Black Belt (Quality Improvement) for Semtech Corporation

Start-up BG Import and Distribution of Medical Devices

Global Quality Remediation project for DepuySynthes

Supply Chain improvement project for Medicareplus UK

SRM Project Manager for MDR implementation for DepuySynthes

Contact this candidate