Quality Engineer AstraZeneca Gothenburg
Alten Sverige AB / Biologjobb / Göteborg
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hela Sverige About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription 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
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-01-18ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-01-31
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4563570
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