Staefa, Switzerland
Design Quality Assurance Engineer
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