As Design Quality Assurance Engineer, you will ensure compliance of R&D processes, deliverables and documents to regulations, standards and good development practices.
Your tasks
Be part of new product development and post-market engineering activities ensuring that quality assurance requirements are met.
Perform required Risk Management activities for Software and Hardware
Ensure the consistency of the technical file documentation
Supporting the project teams to ensure that the products in the pipeline are launched according to plan
Proactively interact with stakeholders
Support FMEAs
Support process improvements
Support with open NCs and CAPA's, as required
Support the internal Audit program as required
Your profile
Diploma/degree in Electronics, Software and/or Mechanical Engineering or equivalent technical field
At least 3 years of practical experience working in a quality related role or equivalent, preferably in Medical Devices
Basic experience in Design Control and Product Risk Management for Medical Devices
Knowledge of ISO 13485, ISO 14971
Ability to understand, interpret and explain device quality regulations to non-quality experts
Well organized and reliable with right level of attention of details
Excellent interpersonal, communication and stakeholder management skills
Good English skills both written and spoken
Good MS Office application skills
Our offer
We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles. Employment level: 100%.
Marcel Huber, Manager Talent Acquisition, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.
For this vacancy only direct applications will be considered