Bruno Gomes

Paul Vouga ***

**** *****-********

Mobile : 004**********

adykd6@r.postjobfree.com

SUPPLY QUALITY ENGINEER

Accomplished and detail-oriented professional with extensive experience managing quality assurance operations, coordinating strategic programmes, and compliance with defined standards / procedures within the medical device and pharmaceutical industry.

Over 10 years of international experience with strong quality assurance and compliance background in medical device and pharmaceuticals, with comprehensive quality systems knowledge.

I am results-driven, dedicated, and accomplished many projects. I have a proven track record of success in

strategic planning, purchasing, inventory management, and supply chain analysis for a top-tier manufacturing and distribution company.

Supply Quality Engineer Abbot

Aug 2021 – Feb 2022

• Supplier Remediation project

• Responsible for coordinating suppliers and verifying quality standards in accordance with the requirement of the company

• Contact vendors and liaise between product engineers, manufacturing personnel to integrated supplier into Global supplier list

• Communicate with vendors regularly to address any concerns and foster an environment that facilitates continual improvement in working relationships

• Compliance with MDR and ISO standards documentation

• Analyses, assessment, verification, and validation of the suppliers to integrate in the Global Supplier list

Consultant UNISUR Import& Distribution of Medical Devices (start-up)

Dec 2019 – March 2021

• Sourcing Management

• Project Management

• Supplier Relationship management

• Procurement Alignment

• Assessment of transport conditions compliance

• Risks assessments and regulatory management

• Documentation

• MDR Compliance

• Staff development

SRM Project Manager for MDR implementation

May 2019 – Nov 2019

• 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

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

• Interaction with the Manufacturing Engineer, Global QA and Purchasing to implement MDR

• Interaction with the suppliers to resolve any issues

Quality Manager

Clestra SA

May 2018 – Nov 2018

• Plan the site requirement of finished goods from Mother Company

• Organize transport and custom formalities

• Control and Check Incoming goods from the manufacturing site and Storage

• Support the Quality Management System

• Development of CTOP (construction turnover package)

• Support company department with general quality and processes development and advice

• Inspection and reporting of Clean Rooms for Biogen constructed by Jacobs

• Document management system

• Create a culture of continuous improvement

Supply chain & Quality Specialist

Medicareplus International –U.K

May 2017 – Dec 2017

• Management of QMS

• Responsible for Import Procurement and distribution of medical devices class I and IIb from China

• quality agreements,

• Development of Technical file

• Supports/lead transport validation/qualification activistes,

• Support Regulatory Inspections from Notified body

• Reporting to the management and Supply Chain team of the performance of the Supply Chain

• Establish a high performance, teamwork culture with a continuous improvement.

• Ensures internal and external customers' expectations and requirements are met.

• Inspection and control of sterile medical devices manufactured and imported from China and UK

• Supplier Quality Agreement

Sr. Manager Procurement / & Logistics

Import and Distribution of Medical Devices

June 2014- Dec 2016

• Responsible for the import and distribution, customs clearances to and from Switzerland.

• Applications/handling of licenses of the health authorities, customs tariff classifications.

• Lead the development and implementation of procurement policies.

• Support tendering, contract management, spent analytics and supplier performance

• Design all processes and implement category strategies that deliver key benefits to the business including financial, service, quality, supply chain optimization and risk management.

• Provide guidance/support to the sales team on material availability, expected delivery dates and lead times.

• Monitor and implement procurement strategies, quality assuring policies, working practices and procedures.

Consultant Quality Assurance (global remediation project)

Depuy Synthes (J&J)-Solothurn

March 2013 to June 2014

• Provided consultancy and guidance related to supplier quality assurance in Medical Devices.

• Supplier Legacy Review (350 cases)

• Supplier Audit, (desktop, site Audit) as per ISO 13485, and FDA 21CFR part 820

• Supplier Evaluation, Selection, Approval, (develop new supplier approval list)

• Develop and coach the team of buyers

• Processes Analyse and development of process flow charts

Project Manager (Lean Six Sigma)

Semtech Corporation - Neuchatel

December 2012 to April 2013

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

• Design, Develop, implementation, improved processes on three sites

• Establish and streamline processes and tools used to drive a robust sourcing process.

• Define KPIs to monitor the performance improvement of the supply chain in all aspects

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

• Ensured the problem-solving improvements and follow-up via a concerns board (PDCA tracking)

• Leading the implementation of LEAN process in the global supply chain organization

Director

Purchasing / Logistics

Pesca and Mar-Jura

January 2011 to December 2012

• Start-up company, built up global supply cold - chain in sea food industry, including all required approvals

• Lead Transport validation / qualification activities. Owner of temperature monitoring process and relationship with the technology vendor

• Responsibility of logistics/ Warehousing / Distribution

• Define, Design, and implement sourcing strategies and processes

• Selection, Evaluation & validation of transport service provider

• Lead global category sourcing & management and contract negotiations

• Import planning and ordering / transportation and warehousing

• Management of Asian suppliers

RUAG Space

Purchasing Manager/Logistics

RUAG Space – Nyon

April 2008 - December 2011

• Overall responsibility of supply chain activities/ logistics and performance of supply chain

• Production Planning and implement via ERP

• Lead contract negotiations and development of long-term partnerships with major suppliers and service providers

• Lead export and import products from USA, Europe, China /customs and transport management

• Lead supplier selection evaluation and qualification

• Experience or demonstrated knowledge of foreign trade (import, export, incoterms, customs)

¢ ¢ ¢ EDUCATION TRACK RECORD OF CONTINOUS LEARNING

2020 Webinar supply chain and quality management

2019 Webinar supply chain and quality management

2018 Tutor for the knowledge Academy

Lean Six Sigma Black Belt (Quality Improvement)

2017 Lead Auditor course (BSI) (ISO 13485-2016)

2016 Global Distribution Practice (GDP certification / Inspired Pharma)

Guideline (2013/C 343/01) in the EU

2015 Investigation and CAPA / Pathwise / Copenague

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

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

2004 ZD Goethe Institute (German language certificate) – Germany

1998 Federal Diploma of Professional Education and Training (Swiss certified Supply Chain Manager Swiss Association for procurement and supply chain)

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

2013 Johnson & Johnson (various FDA’s Quality System Requirement (QSM Training)

The Elements of Quality System

Purchasing Controls Regulatory Requirements Overview

Root cause Analysis guidance Document

Failure Investigation Process and Problem-Solving Process

Receipt of Product Complaint and Adverse Event Information

Risk Management Policy – ICDS

GMP/UDI/GDP

2012-2013 Project Management (Black Belt Lean Six Sigma)

2002 Auditing skill workshop / Internal Auditor ISO 9001

2002 Ariba software training / London

2001 Microsoft licencing seminar / Lausanne

1992 Accountancy Course / Neuchâtel

¢ ¢ ¢ LANGUAGES

English Mother tongue,

French High level

German Middle level (intensive course /Koln/Germany)

Portuguese Basic

¢ ¢ ¢ SOFT SKILLS

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

¢ ¢ ¢ COMPUTER KNOWLEDGE

Computing: Ms Office, Ms Project, PowerPoint, Outlook

ERP: SAP- MM Module / CAM / Mapix / JD.Edward / Ariba / MRP, Minitab

¢ ¢ ¢ PROJECT MANAGEMENT

Major Warehousing project for EM Microelectronic

Major IT project (Data center for Europe) Autodesk,

Project Implementation of SAP MM Module, Purchase to Pay Ariba, in Europe

Logistics: Distribution of Harware and Software in subsidiaries in EU (Autodesk)

Delocalisation project in India and Malaysia (Danaher Motion)

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 Import and Distribution of Medical Devices

Global Remediation Quality project for DepuySynthes

SRM Project Manager for MDR implementation

Supplier Remediation project

Contact this candidate