Supports the design controls process during development of new medical devices or design changes including: Planning, Design requirements, Design Validation and Verifications, and Design transfer specifications.
Support Design related root cause and corrective action investigations
Lead the Usability Engineering activities including: Usability strategy plan, Usability strategy report, Formative and Summative Evaluations.
Review and approve Engineering documentation, such as: Design controls deliverables, CAPAs, NCs, CCPs, etc.
Coordinates the creation, review and updates of Risk Management Files and Reports for all applicable product families along with the Ops Quality and the Quality System departments.
Other functions may be assigned by management based on his/her knowledge and experience.
Requirements
Bachelor´s degree in Industrial Engineer, Quality Engineer, Industrial Production Engineer, Biomedical Engineer, Mechanic Engineer, Chemical Engineer, Material Engineer
2 years of Experience in Medical Industry within Quality Department