Quality Engineer at AstraZeneca Gothenburg
Dfind Science & Engineering AB / Kemiingenjörsjobb / Göteborg
2019-01-17
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AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of rescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The Arena:
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
Minimum requirements:
• 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
• Preferred experience and key factors
• 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
Preferred experience and key factors
• 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
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2019-01-30. Selection is on-going and interviews will be held continuously which means the position can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Kerstin Karlsson
kerstin.karlsson@dfind.se or Malin Wåhlber
malin.wahlberg@dfind.sePlease keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-01-17ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-01-31
Ange följande referens när du ansöker: 201198120
Klicka på denna länk för att göra din ansökanKontaktKerstin Karlsson
kerstin.karlsson@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41110 GÖTEBORG
KontorsadressSödra Hamngatan 35, 41110 GÖTEBORG
Jobbnummer 4562461
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