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Compliance System Engineer

   Back Region: Belgium Kind of contract: Open-ended Work regime: Fulltime Location: Louvain-la-Neuve
Retour Région: Belgium Type de contrat: Open-ended Régime de travail: Fulltime Lieu: Louvain-la-Neuve
Zurück Region: Belgium Art des Vertrages: Open-ended Arbeit Regime: Fulltime Standort: Louvain-la-Neuve
  返回 地区: Belgium 样的合同: Open-ended 工作体制: Fulltime 地点: Louvain-la-Neuve

Job Description

Description de l'emploi

Stellenbeschreibung

工作描述

Internal & external posting


Mission:
PT Services – Service Engineering team (30 people) is leading the technical management and work for the update and upgrade of the installed base along with the support and configuration for sites under installation phase.
As a member of the PT Services – Service Engineering team you responsible to support a Quality culture within the team by driving compliance activities and managing risk assessment through the development and deployment life cycle.


Duties and responsabilities:
  • Ensure compliance of our products to international standards (such as IEC 60601-1, 60601-1-2, 61010, 60204, EN 55011, IEC 60601-1-3, 60601-2-64, 60601-2-68, …) and define specific requirements derived from these standards to components
  • Support development teams, testing teams and laboratories in their tests of system or sub-systems; lead projects of certification to aforementioned standards (project and technical support)
  • Determine strategy to ensure the compliance of new developments to applicable ISO / IEC Standards
  • Supporting and coaching development teams in the application of these standards and industry best practices during all phases of the product lifecycle.
  • Validate compliance of new developments to ISO / IEC Standards
  • Act as a single matter expert across the departments concerning compliance to industry standards

Profile

Profil

Profil

简介

You have :
  • a master degree in engineering (electrical, electro-mechanical, electronics), science (biology, chemistry, physics) or from a similar background.
  • A strong knowledge of electrical safety compliance preferably for large-scale medical device industry. Knowledge of Electro Magnetic Compatibility compliance is a plus.
  • 5 years’ experience in applying IEC/ISO standards, preferably in the medical device industry.
  • Relevant experience in submitting devices to certifying laboratories for safety or compliance.and in Risk Analysis and Management for Projects (RAMP).
  • Experience with a requirements management tool such as DOORS and in specifying requirements for large-scale, complex systems is an asset.
 
And you are :
  • Able to organize your work autonomously and to take initiatives.
  • A team player having the passion to communicate/listen/influence others in view of reaching your objectives.
  • You like helping others with sharing of your experience and knowledge.
  • Quality minded.
  • Given the international environment, you have full professional proficiency in English (verbal and written). French is a plus.
  • Willing to travel worldwide (< 10% of your time).

Company

Société

Unternehmen

公司

IBA : opening new ways in the fight against cancer.
IBA is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy. The Company’s expertise lies in the development of next generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including IBA’s leading fully integrated IntegraLab® radiopharmacy system, and Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety.

Headquartered in Belgium and employing more than 1,500 people worldwide, IBA currently has installed systems across Europe and the US and is expanding into emerging markets.
The Company is focused on providing solutions in the fight against cancer.

Offer

Offre

Angebot

聘用意向书

IBA offers you the opportunity to realize great achievements in the fight against cancer. Our employees are perceived as passionate, pragmatic and result oriented people dedicated to develop leading edge technologies to protect, enhance and save lives !

If you are stimulated by multicultural challenges and willing to travel, we offer you the opportunity to join a team of more than 35 nationalities working on more than 40 different sites on 3 continents.

IBA offers you a competitive performance based compensation package and a flexible work environment. You have real possibilities to evolve within IBA's worldwide, leading organization and to create your own career path, supported by training programs to acquire new skills and ensure they stay sharp.

As an Equal Opportunity Employer IBA is committed to a diverse workforce.

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Compliance System Engineer

Region: Belgium Kind of contract: Open-ended Work regime: Fulltime Location: Louvain-la-Neuve

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