Quality Specialist
Permobil AB / Maskiningenjörsjobb / Stockholm
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Sollentuna,
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hela Sverige Would you like to work in an international environment where you'll make a difference every day? At Permobil, we're looking for game-changers to join us as we innovate for individuals and develop the world's most advanced assistive solutions.
At Permobil, the people who use our products come first. Our purpose is to create advanced assistive solutions that make the lives of adults and children living with disabilities more enriching. Our people are passionate about pushing the boundaries of technology to deliver innovations that improve lives. We are a sustainable and responsible business committed to continuous improvement, and our customers can trust us to provide market-leading solutions driven by insights-based clinical data.
We are now looking for a Quality Specialist who will support management of the regional QMS including primarily the manufacturing sites and global functions working within the QMS. You will be a part of a team working together to support the organization where team members also have primary areas of responsibilities as QA for certain functions and QMS processes. Furthermore, it is part of the role to help coordinate and support on-site audits conducted by external providers or authorities, both during audits and with follow-up of findings and corrective actions, as well as, initiate and/or lead projects to improve quality assurance processes and monitor risk management activities.
Key Duties
In this role you will develop and manage assigned processes and supporting eTools within the QMS, supporting the organization to continuously improve the quality system. The focus in this role is the Document management process including the EDMS and supporting IT as QA computerized system / software validation.
QA support for our Seating and Positioning manufacturers in EMEA
Risk Management inkl Process Risk Management
Change and Deviation Management Processes
eQMS support - eQMS project feasibility starting 2023
Location: Kista
Required Knowledge and Experience:
Master degree or Bachelors degree preferably in science and engineering and t least 2 years of working experience
Good knowledge of quality systems, within the Medical Device or Pharma industry
Previous experience of regulatory requirements for medical device (Class I EMA & Class II US) in accordance with MDR 2017/745 and ISO13485
Good knowledge of software validation (GAMP and 21 CRF part 11)
Knowledge of risk management (ISO 14971:2019)
Strong computer skills including Microsoft Office
Fluent in English both oral and written.
Fluent in Swedish both oral and written (meritorious)
To succeed in this role you have personal drive, attention to details and great problem solving capabilities. We are looking for a team oriented person with great communication skills. In this role it is important to have the natural characteristics of influencing and having the ability to develop efficient processes.
Why Permobil is a great next step for you!
You'll make a difference. Every day
Everything we do leads to understanding and improving the lives of our users. Through our evidence-based innovation, we make a difference to people's lives.
You'll make your mark as part of our future
We collaborate with colleagues across borders to Innovate for Individuals. The impact you make personally could lead change around the world.
You'll feel welcome from day one
We're known for being great colleagues, who are collaborative, fun and at the cutting-edge. Everyone in the Permobil family cares as much as you do about making a positive difference.
Information
Please apply via our career page as soon as possible. We will conduct selection continuously so send us your application today!
For more information about the position, please contact Zara Marzouki at
+zara.marzouki@permobil.comFor information about the recruitment process please contact HR BP Maria Myrén at
maria.myren@permobil.comPlease respect that we do not wish recruitment assistance or advertising, we decline calls from recruitment and advertising providers.
More about Permobil
Permobil founder Dr. Per Uddén believed that helping people achieve the greatest level of independence is a basic human right and, for over 50 years, Permobil has held fast to that belief. Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users' needs and improving their quality of life through state-of-the-art healthcare solutions. Today, those solutions include power wheelchairs, seating and positioning products, power assist, and manual wheelchairs.
Permobil is part of Patricia Industries, a subsidiary of Investor AB, and is headquartered in Sweden. Permobil has 1600 team members in more than 15 countries around the world. For more information regarding the company's storied history and complete product line, visit permobil.com.
Fun facts about us: One of our products was 1 of 100 best inventions in Time magazine in 2021
https://time.com/collection/best-inventions-2021/https://time.com/collection/best-inventions-2021/6112517/permobil-explorer-mini/ Så ansöker du Sista dag att ansöka är 2023-01-06
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Permobil AB (org.nr 556113-3496)
Arbetsplats Kista
Jobbnummer 7258373
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