Quality Engineer
Dfind Science & Engineering AB / Maskiningenjörsjobb / Göteborg
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The arena:
AstraZeneca has a long-standing reputation as being a leader in advanced Drug Delivery products. At the beginning of 2016, Pharmaceutical Technology and Development (PT&D) became an integral part of Global Operations. A global organization with 1,100+ workforce disbursed across UK, Sweden, Germany, US and China, with additional colleagues located at key manufacturing sites. We support launched and development portfolios.
With innovation at the center of everything we do, we design and deliver the active drug product (including formulations, devices and packaging) required to support new medicines - from products to be used in toxicology studies and clinical trials to development of the technology to ensure that drug products can be scaled up for manufacturing on a commercial scale.
Inhalation Product Development (IPD) Device & Packaging Gothenburg is a team within Pharmaceutical Technology and Development (PT&D) and our team focuses on designing and developing devices for inhalation drug administration and packaging of pharmaceuticals and devices. We are looking for an experienced Quality Engineer to be part of the development team for one of our inhalation device projects. The job holder will be part of a Design core team, who will work closely with other core team engineering leaders; e.g. Design, Test, Quality, Human Factors, etc.
The role:
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
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
• 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
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-06-01. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Sara Kuikka
sara.kuikka@dfind.se 0725-487688
Please 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 second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-05-23ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-06-01
Ange följande referens när du ansöker: 201150474
Klicka på denna länk för att göra din ansökanKontaktSara Kuikka
sara.kuikka@dfind.se 0725-487688
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 4162342
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