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QA- RA Engineer- Medical Devices- Biel & Neuchâtel areas

Altran AG

 
Umgebung Biel und Neuenburg
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Altran AG

Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: the world leading engineering and R&D services of Altran – acquired by Capgemini in 2020 - and Capgemini's digital manufacturing expertise.

With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defence, and consumer products..

QA- RA Engineer- Medical Devices- Biel & Neuchâtel areas

Our Offer 

  • A permanent contract with the leader in innovation and high-tech engineering consulting
  • A multi-stage model with career opportunities through specialization prospects, as well as through continuing professional education and training
  • Helping clients to realize ideas from ideation, prototyping, industrialization of products, manufacturing, scale-up, distribution as well as service provisioning/support
  • Global projects & global job opportunities

Your Role 

  • Be aware about new Medical Devices Regulations 'MDR'
  • Ensure continued alignment with Regulatory Affairs teams (global and local) requirements and planning.
  • Collaborate actively on selection of suppliers and establishment of contractual documents.
  • Ensure direct and continued contact with supplier teams through team meetings and document review.
  • Act as quality management representative in project teams.
  • Initiating improvements to the Quality Management System, ensuring compliance to all relevant quality standards and regulatory requirements.
  • Handling customer complaints.
  • Investigating deviations and non-conformities in cross-functional teams.
  • Reviewing batch records and release.
  • Review and proactively assist in process capability studies and statistical techniques as required, to support continuous improvement

Your Profile 

  • Master or Engineering Degree in quality engineering (EPFL, ETH, HES or equivalent).
  • Min 5 years of experience as QA/RA manager in the medical devices industry with crossfunctional experience in international environment.
  • Excellent knowledge of ISO13485, ISO 14971, MDR.
  • Languages : English fluent

Adresse

Capgemini Engineering
Madame Alix Bon-Mardion
Recruiter
Avenue de Rumine 13
1005 Lausanne

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