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Quality Manager

Location:
Veytaux, Vaud, Switzerland
Posted:
January 08, 2020

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Resume:

Bruno Gomes

Paul Vouga ***

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

Mobile 079*******

ada8o5@r.postjobfree.com

QUALITY MANAGER

It is very rewarding for me to share my knowledge and experience around the acute challenge the business face in the quality management, process and product improvement area Confident, dynamic and results-oriented quality assurance professional, with extensive experience evaluating and analysing vendors and suppliers to ensure selection of most qualified contractor. Demonstrated ability to develop and implement work processes and KPI’s that improve the reliability and flexibility of the supply chain management. Interpersonal, networking, analytical, conceptual, communication and negotiation skills, Auditing of Medical Device Suppliers, Complaint handling, Purchasing Control Working knowledge of FDA Regulation 21CFR part 820,GMP Guidelines, ISO 13485:2016, ISO 9001:2003), Lead Auditor (19011:2011, Quality systems for Medical device companies, Working Knowledge of Medical Devices Directive 93/42/EEC, MDR/745, Quality Systems, Process excellence (six sigma black Belt project management ) skilled at leading cross-functional teams. Personable and effectively manages relationships with all stakeholders. Quality supplier agreements, Contract review for suppliers, Data Mining, enforcing quality measures, Sustainability management, Ensuring compliance, Professional handling of all level of management regarding regulatory requirement, Review of measures for supplier assurance at all levels, supplier development-change agreements. Documents control.

AREAS OF EXPERTISES

QMS Maintenance and Quality Manual

US FDA Regulations 21 CFR part 820

Gap Analysis of ISO 13485:2012 to 13485-2016

Gap Analysis of Directive CEE 93/42 to MDR/745

Knowledge of ISO 9001:2015

Auditing ISO19011:2011

Knowledge of ISO 14971

Regulatory affaires

Technical Product File, Technical quality Agreement

Internal & External Audits

Legacy Review & Remediation of suppliers

Document Control

Lean six Sigma Black Belt Project Management

Root Cause Investigation and Analysis

Value Mapping

Process Improvement

Investigation & CAPA

KPI’S

Supplier Quality Management

Supplier Selection, Evaluation, material qualification, supplier performance, monitoring & supplier related non-conformance

Assessment of supplier capabilities through direct visit, technical discussion and quality audit

Knowledge of GMP, GDP,UDI

Sub-contracting Manufacturing of medical devices

Inventory management

Logistics & Distribution

Supply Improvement

Relationship Management

Implement Training

EXPERIENCE

SRM Project Manager for MDR implementation

May 2019 ---

Key Responsibilities

• 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

Clestra SA (sub contract Biogen)

Quality Manager

May 2018 – Nov 2018

Key Responsibilities

• 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

Quality Specialist

Medicareplus International U.K

May 2017 – Dec 2017

Key Responsibilities

Quality and Regulatory affairs

- Implementation and management of the quality system compliant with current standard ISO 13485, European regulation;

- First interlocutor for Notified body, FDA, and customers audits;

- Internal and supplier lead auditor;

- Responsible for the process validations;

- Owner of the incoming and production quality control processes;

- Quality team member for external audit for the group Medicareplus (MHRA, Notified body);

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

- Gap analysis for certification of ISO 13485-12 to ISO 13485-2016

- Gap Analysis of MDD to MDR

- Create and Update Technical files as per the requirement of MDR

- Technical support for product registration in different markets (USA, Canada)

- Responsible for technical files products for CE Mark approval (Class I and, IIb devices);

- Risk management as per the ISO 14971:2012

- Knowledge of Biocompatibility - ISO 10993

- Management of improvement projects

- Owner of the customer complaints and vigilance processes;

- Change Management

- Supporting external manufacturing of medical device (China)

QA&RA Manager

BG Import & Distribution of Medical Devices

Sept 2014- March 2016

Key Responsibilities

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

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

• Responsible for the quality oversight of the products distribution.

• Participate/ Assist and lead during Notified body, Customer assessments/audits/inspection

• Participate/Assist in the Supplier Management process

• Participate in and coordinate CAPA process

• Coordinate the complaint and internal audit processes

• Communicate risks and compliance/regulatory issue to management

• Participate in continuous improvement activities

• Develop Employees training matrix

• Lead key projects for improvement the quality system and other critical business projects

• Provide technical support and guidance to assure product quality and conformance

• Knowledge of MDD Directive (CEE 93/42), ISO 13485-2016, FDA 21CRF part 820

• Development of Technical documentation, CE marking

• Regulatory Requirement of Swiss medic and authorization

• Support receiving inspection activities and audit receiving inspection process and inspectors

• Internal Auditing

• Undertake any assignment or duty as required by business needs

• Expertise in Logistics, Warehousing, Distribution

Consultant Supplier Quality Assurance

Depuy Synthes - Switzerland

June 2013- June 2014

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.

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

• Legacy Review & Remediation of Suppliers Quality system

• Non-Conformance Management

• Provide support for activities related to supplier selection, evaluation, material qualification, supplier performance monitoring and receiving inspection.

• Audited suppliers and facilitated creation of new supplier quality agreement.

• Desktop Audit & Site Audit

• Supported in process quality and compliance review by monitoring Key Quality indicators (KQIs) and ensuring that gaps are addressed appropriately to mitigate risk.

• Reviewed measures for supplier assurance at all levels - inter alia of certifications and accreditations as well as segmentation of suppliers for commercial and regulatory requirements.

• Developed and improved supplier base and Approve supplier list

• Performed supplier assessments, trend analysis, and risk analysis, analyzing current supplier performance issues, and defining and implementing corrective actions to ensure their timely resolution.

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

• Supported /Initiates investigations for non-conformances

• Training for the buyers

Project Manager Lean Six Sigma Black Belt

Semtech Corporation - Switzerland

December 2012 to April 2013

• 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

• Creation and Maintenance of all relevant project documentation

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

• Developed effective strategies for the project which meet business goals

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

• Analyze and measures supplier quality performance (KPI)

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

• Knowledge of FMEA, Fishbone Diagram, 5 Why, SPC, Brian storming

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

• Value Mapping, Root cause analysis

• Monitored and communicated progress on project and resolved internal issues

Director

Pesca and Mar Switzerland- Switzerland

January 2011 to December 2012

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

• Define and support of implement Sourcing strategies

• Lead strategic Sourcing & global Commodity Management

• Internal Auditor

RUAG Space

Purchasing Manager

RUAG Space – Switzerland

April 2008 - December 2011

• Lead Procurement activities, reduced time required for purchase requisition approval from 1 week to 2 days, and eliminated backlog of approvals, by migrating Purchasing requisition categorization process to centralized team.

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

Analyze supplier quality performance (KPI) and measures to bring the respective suppliers to the required quality level

• Internal Auditor

Senior Buyer

Petroplus Refinery Cressier Switzerland

September 2007 - December 2007

Contract Buyer

DePuy Synthes – Switzerland

August 2006 to August 2007

• Lead procurement and outsourcings services

• Manufacturing of quality processes based on GMP

• Lead subcontracting, outsourcing and manufacturing operations in EMEA and USA

• Internal Auditor

EDUCATION TRACK RECORD CONTINOUS LEARNING

2018 Webinar: MDR, MDSAP

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 procurement (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

• 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 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



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