Claire Robinson

Claire Robinson

Global Quality Management System Manager, ResMed
 

Currently employed at ResMed

Previous: ResMed Group, Gründler Medical, GE Healthcare, ResMed Ltd, ResMed Paris (SAIME)

 

Previous: NSW Enterprise Workshop, Télécom Physique Strasbourg (Ex ENSPS), Lycée Francois 1er

 

    Summary

    After a master in biomedical engineering, I was introduced to the world of quality and audits in the medical device industry which was a great way to discover the whole business from design and marketing to manufacturing and facilities. Over the last few years, I had the opportunity to live and work in Australia, France and Germany, audit more than 50 different production facilities in over 10 countries and improve business processes in compliance with quality requirements in various departments. My current role is QA/RA manager at Gründler Medical, a German company part of the ResMed Group. I am the happiest when facing a failing process or system, reviewing it, analyzing data and implementing improvements and strategies to make it the most appropriate for the business. Outside of daily work, I appreciate organizing events and communicating about my companie's business and achievements. And during leisure time I enjoy travel and photography. Skills General Result Orientation, Leadership, Organization, Communication Quality Assurance Process Design and Improvement Audit and CAPA Management Regulations: ISO9001:2008, ISO13485:2003, FDA Part 820, CMDCAS, Medical Devices Directive 93/42/EEC, Japanese regulation, ISO14001 Management Team Management (Internal auditors, Enterprise Workshop) Project Management (QA software implementations, Service strategy) Change management (Introduction of major new quality/business processes) Event Management (Open day, Gala)

Experiences

Global Quality Management System Manager

At ResMed

From August 2014 to Present
Develop the global quality management system: - vision - structure - documents Lead implementation at all imapcted sites
 

Manager - Quality Assurance (QA) & Regulatory Affairs (RA)

At ResMed Group, Gründler Medical

From April 2012 to July 2014
Management of all Quality and Regulatory Affairs activities for Gründler Medical a ResMed company, including: QA - Updating system to FDA requirements - Integrating system with ResMed global Quality system - Scaling system for increased production and distribution RA - Registring new products...
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Production & Process Controls QA Manager

At GE Healthcare

From April 2011 to February 2012
Management of the production and process control team (4 to 6 QA engineers and technicians) Provide guidance and ensure control over design transfer and production processes Lead compliance to standard and to global quality system Part of the core team for 2 mock FDA inspections Part of the core...
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QA Project Manager

At ResMed Ltd

From 2010 to 2011
Define ResMed global after-sale service strategy for the next 5 years: - Map the current after-sale service organisation and processes - Lead a consulting team for an after-sale service benchmarking study - Facilitate discussions with commercial leaders to define global strategy - Define the...
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QA Manager - Audits

At ResMed Ltd

From 2008 to 2010
Responsibilities - Manage the internal and supplier audit team - Manage external audit (ISO, Mock FDA, TGA, CSA, customers) - Ensure approval and control of suppliers Achievements - Design and implementation of new risk-based supplier control process later duplicated by other ResMed entities...
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NSW Enterprise Workshop, Sydney

Business sponsored education program on commercialisation and entrepreneurship , NSW Enterprise Workshop

2009
Awarded Best Business Plan for winter 2009 session (team of 5)
 

QA Engineer - Audits

At ResMed Ltd

From 2007 to 2008
Responsibilities - Develop an internal audit process and program - Create, train and manage internal auditors - Manage external audit (ISO, Mock FDA, TGA, CSA, customers) Achievements - Creation of efficient GMP focussed internal audit program - No major ISO non-conformances and reduction...
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Documentation Quality Engineer

At ResMed Paris (SAIME)

From 2006 to 2007
Achievements - Development of Device Master Records management process - Design and implementation of change control process - Implementation of the document control software Objective (structure, control processes, training, transfer strategy)
 

TFE Quality Assurance Assistant

At GE Healthcare

2005
Achievements - Development of quality training system with effectiveness check - Set-up of document control system for X-Ray Tubes department
 

Lycée Francois 1er, Le Havre

High School Diploma, major in science, Lycée Francois 1er

From 1996 to 1999
with honours
 

Skills

 
  • Audit
  • Medical devices
  • Project management
  • QA
  • Quality

Langues parlées

 

Centres d'intérêt

 
  • Event management and communication
  • salsa dancing
  • travel and travel photography