Engineer in Quality Assurance and Technical Support

Thierry KUB

Belgium

Email: **********@*****.***

Birth date: October, 1980 (36 years old)

Married

http://be.linkedin.com/pub/thierry-kubwimana/23/615/a71/

BIO ENGINEER Specialized in Quality Assurance and Technical Support

WORK EXPERIENCE

08/2013 – Present Clinical Technical Support Engineer, LivaNova PLC (Ex. CYBERONICS Inc.) – Diegem, Belgium

Project title: Technical support and Complaint handling in the Clinical and Quality department.

(VNS Therapy® “Vagus Nerve Stimulator Therapy” and CRM “Cardiac Rhythm Management”).

- Providing clinical and technical support related to the medical device products (VNS Therapy and CRM), especially in customer experience and technical/scientific expertise,

- Complaint investigations in accordance with Company policy, FDA and international regulations,

- Regulatory reports submission (MDR, MEDDEV, TGA) regarding product issues, adverse events,

- Troubleshooting of events with customers and/or commercial teams,

Researches solutions to questions or problems (eg. Therapy system questions, product issues) and provides answers according to labeling, specifications and clinical or technical data,

- Training and maintains current knowledge regarding the Therapy programs, products and services

- Provides technical expertise and knowledge in workshops, product demonstrations and during implant surgeries.

05/2012 – 04/2013 Operational Bulk Support Engineer, GlaxoSmithKline Vaccines (GSK Bio) – Belgium

Project title: Deviations and CAPA notifications management (Calibration and Measurement C&M – Environmental Monitoring – Production equipment preparation & Cleaning).

- Planning and follow up of C&M activities of GSK Bulk equipments,

Tracking, investigating, monitoring and management of C&M gaps (E6 notifications) in SAP,

- Deviations Handling in SAP (according to the GSK requirements and cGMP regulations),

- Deviation investigations leading: Potential product impact / Root cause analysis using quality tools 6M, 5Why, Fishbone... (Working with QA, production, C&M and maintenance teams),

- Implementation of CAPA plans, KPI’s and change control to improve activities,

- Operator’s trainings and sensibilizations according to the CAPA plans and the context.

01/2011 – 03/2012 Quality (Quality Assurance / Quality Management) Coordinator, BIOCIE Pharma Equipments – France.

Project title: Quality Management System implementation project and routine QA activities.

- Implementation of the ISO Quality Management System,

- Prepared and conducted staff trainings on the ISO 9001 / ISO 13485 requirements,

- Conducted processes audit (malfunctions analysis, identification of causes) in cGMP environment,

- Gap analysis, Process Deviation handling, CAPA implementations and change control,

- Developed and written Quality manual, SOP’s, procedures and GMP documents.

INTERNSHIPS:

04/2010 – 11/2010 (Internship) Quality Assurance and R&D Engineer, TIPPAGRAL SA - France.

12/2008 – 08/2009 (Internship) BioProcess Research Engineer, National Institute for Agricultural Research (INRA) - France.

12/2007 – 07/2008 (Internship) QA & Validation Engineer - SAIDAL Pharmaceutical Group, Algiers – Algeria.

06/2007 – 10/2007 (Internship) Quality control Technician - DANONE CLOVER Limited – South Africa.

LANGUAGES

French - Fluent

English - Fluent

Dutch - Basic

Arabic - Basic

Swahili - Intermediate

COMPUTER - IT SKILLS

Proficient: MS office (Word, Excel, Power Point, Outlook, Visio), Lotus notes 8, Sage 100, Internet, Adobe.

Working knowledge: SAP, MS Project, MEGA process, ETQ, Remetrex, VBA

INTERESTS AND ADDITIONAL INFORMATIONS

SPORT: Cycling team or individual (Bike/ATV’s), Fitness, Judo, Basketball Cinema and travelling

Geopolitics and strategies Driving license

Full mobility (National and international)

EDUCATION & TRAINING

2010 - Postgraduate degree: Complementary Master in Sciences, Technology and Health

Course: Quality Management & Financial control.

AGROSUP Dijon Engineering School – France.

2009 - Postgraduate degree: Master of Research in Sciences, Technology and Health

Course: Microbiological process and Quality.

ENSBANA Engineering School in Biosciences – France.

2008 - Bio-Engineer’s degree in Biological sciences,

Course: Quality control and Analysis.

University of Sciences and Technology of Algiers – Algeria

RECENT TRAININGS

Cardiac Rhythm Management – Bradycardia Master Course

ISO 13485 – Quality and complaint management

Clinical support and Technical expertise in medical devices (Active implantable devices)

International regulatory reports (MDR, MEDDEV, TGA, CFDA) submission. Project Management based on PMBOK guide

Risk Management

cGMP

Navigation within SAP

Deviation and CAPA notification Management

Calibration & measurement Management in Pharma

Test of English in International Communication – TOEIC.

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