Quality Engineer consultant to AstraZeneca in Gothenburg
MODIS Life Science is now looking for a Quality Engineer Consultant for an assignment at AstraZeneca in Gothenburg. This is a 12-month assignment, starting asap. Send your application no later than October 17th.
As Quality Engineer you will be a key of a cross functional development for the development of an inhaler. You will ensure that the projects are delivered with the highest quality and compliant to requirements from Health Authorities, Regulations and Standards. You will be responsible to ensure that the right processes, procedures and best practices are executed and implemented in the projects.
Activities typically includes, but limited to:
- Work proactively with development team to plan, develop, and deliver medical devices and combination products that are of the highest quality and also satisfies user needs.
- Ensure project team follow processes, procedures, ways of working and templates
- Ensure the project is compliant to applicable regulations, laws and standards
- Facilitate risk assessment events and ensure that risks process is executed
- Provide expert knowledge to the project team when it comes to GXP ways of working
- Ensure documentation are written a quality and regulatory way
- Be a link between the QA, Medical Device Regulatory Affairs and the project team
- Work with other Quality Engineer to drive harmonization across project and execute quality engineering initiatives
- Author DHF index and Essential Requirements List
- Ensure high quality and compliant DHF by review project team documentation
- 5+ years´ experience working in development of medical devices or other relevant regulated industry
- 3+ years´ experience working in a Medical Device Quality or Regulatory department
- Extensive understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4
- Experience in establishing DHFs, Technical Files and Dossiers
- Good understanding for medical device technical standards; ISO, IEC FDA guidelines
- Excellent organizational and communication (oral and written) skills.
- Ability to work on teams as well as individually
- Ability to be pragmatic but still be compliant to solve problems
- Good leadership and interpersonal skills
- Good technical and regulatory writing skills
- Fluent in English
For questions, please contact email@example.com