We are, on behalf of our customer Astra Zeneca in Gothenburg looking for a Quality Engineer. Please state ref. 750087 if you respond to this request. The assignment is to start as soon as possible (the mentioned date is preferred).
As Quality Engineer you will be a key person in a cross functional development team(s) for the development of inhalation devices and Combination Products. 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.
Tasks and responsibilities/The role, but not limited to:
- Work proactively on Quality Engineering tasks 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 that the project team follow processes, procedures, ways of working and templates
- Ensure the project is compliant to applicable regulations, laws and standards
- Facilitate risk assessment tasks 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 and follows Design Control.
- Author DHF index and Essential Requirements List
- Ensure high quality and compliant DHF by review project team documentation
- Be a link between the QA, Medical Device Regulatory Affairs and the project team
- Work with other Quality Engineers to drive harmonization across project and execute quality engineering initiatives
- 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
- Experience working in the Pharmaceutical industry and combination product highly preferred
- 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.
- Good technical and regulatory writing skills
- Fluent in English
- 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