Device Quality System Lead Expert

Posted 22 Feb 2019

Coinsins, Vaud - Switzerland

Req Id 184399

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role: Reporting to the Head of Device Quality System, you are supporting the compliance of the quality system for delivery systems for injectable drugs and associated e-health software applications: documentation control, training and awareness, change control, internal and supplier audits, non-conformities, corrective and preventive actions, management review, Key Performance Indicators, Regulatory intelligence. You ensure the continued certifications of the quality management system based on ISO 13485 and of the information security management system based on ISO 27001 and you facilitate their improvement and compliance with international standards and regulations, as well as alignment with our policies and standards.

 

Who you are:

  • Master (or equivalent) degree in science, engineering or related field
  • 5 to 8 years of experience in medical device quality system
  • In-depth expertise of quality system for medical devices, ISO 13485, 21 CFR 820, MDSAP
  • Good knowledge of information security management systems, ISO 27001, GDPR
  • Training to global medical device regulations, CE marking, 21 CFR
  • Training in IT systems compliance (data security, data integrity, regulatory)
  • Fluent in English
  • Auditor Certification is a plus
  • Experience with medical devices and software development good practices is a plus

What we offer: We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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