Quality Engineer to Getinge
Engqvist & Zimmerman HR Partner AB / Civilingenjörsjobb / Växjö
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Working at Getinge
Getinge is in an exciting and intensive period of change and we are now looking for a Quality Engineer to our QA team in Växjö. As a Quality Engineer you will be a member of Regulatory affairs and this position offers you a opportunity to work cross-functional locally and globally with a wide variety of stakeholders inside the organization.
Work description
The Quality Engineer is responsible for providing regulatory compliance strategies and ensuring successful product compliance for R&D and sustaining projects as well as ensuring that the procedures according to valid QMS are performed to a correct level.
You will also participate in product development projects to ensure that the interpretation of regulatory requirements is performed to the correct level of compliance with a global approach.
Among your main responsibilities and tasks will be:
Development of regulatory strategies supporting R&D product development projects and coordinate the preparation of technical files
Ensure that product compliance is maintained during design change activities
Be knowledgeable with the applicable standards, regulations, and directives that are required for ensuring product compliance.
Support market registrations in different countries
The position is located at our site in Växjö and you will be reporting to the Manager of Quality. International travel is expected on an occasional level.
Who are you?
As a person you are action-oriented, driven and independent with a great amount of integrity. To succeed in the position you must have excellent documentation skills.
You are strategic thinking but pragmatic with a strong ability to make decisions. You also have a coherent, challenging and process-oriented attitude and an excellent ability to communicate and collaborate with both internal and external stakeholders.
The Ideal Candidate
Bachelor or Master Degree in field medical device, electronics, mechanical engineering or similar
3-5 years of experience in Quality Management / Reg. Affairs or related functions within a medical device or other regulated environment
Previous background and experience within other related functions, including product development, manufacturing, and operations
Experience and good knowledge in applicable regulations and standards, e.g. FDA Quality Systems Regulations (21 CFR Part 820), ISO 9001, ISO 13485, ISO 14971, CMDCAS, MDD and product standards (e.g. machinery Directive, IEC 61010)
Good Swedish and English skills, oral and written
Position details
Full time, starting date on agreement.
Placement
Växjö
Contact information and application
Apply with CV and cover letter. If you have any questions about your application or our process, please contact: Linda Engqvist, 0733-40 44 54 or send and e-mail to
linda@engqvistzimmerman.seTime schedule
We want your application as soon as possible as we handle all application on an ongoing basis. Apply before January 31st.
We welcome your application!
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2020-01-17ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2020-01-31
Klicka på denna länk för att göra din ansökanFöretagEngqvist & Zimmerman HR Partner AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Engqvist & Zimmerman HR Partner AB (org.nr 559160-6370)
Arbetsplats Engqvist & Zimmerman HR Partner
Jobbnummer 5046037
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