About this role
Role Overview
- Be the QA focal point design and development of projects throughout the product design process until transfer to production
- Provide quick solutions to inquires and problems arising during the process
- Control all aspects of project documentation
- Interface with relative personnel to resolve document problems/issues within the design process
- Be a customer facing team member and represent the organization and QA needs to the customer
- Assist in cases of non-conformities (NC) of products, parts and processes
- Supporting production readiness activities and validations
- Perform investigations and collect data on deviations of parts, materials or processes throughout the organization, while working with other departments
Requirements
- Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar
- an advantage
- CMQ / CQE or similar
- an advantage
- At least 2 year of experience in working according to GMP and regulatory requirements (FDA QSR part 820, ISO 13485) – mandatory
- Previous experience in QA design work – significant advantage
- Experience with QMS and production
- significant advantage
- Experience in the field of Medical Devices
- an advantage
- Good knowledge of MS-Office tools (Excel, Word)
- Acquaintance with E-Document management systems
- English
- high level (written and spoken)
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development