Quality Assurance Specialist
Poolia Sverige AB / Civilingenjörsjobb / Sundsvall
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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.
Responsibilities
To our QA/RC team we are looking for a Quality Assurance Specialist focusing on production, supply chain and related product realization activities for Power wheelchairs in Timrå. In this role you will develop and manage assigned processes within the QMS, supporting the organization to continuously improve the quality system. You will also work with approving quality documents, participate in and approve risk assessments, and records such as eg CAPAs and changes.
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. Location: On Site Timrå/Sundsvall.
Key Duties
In this role you will 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
• Ensure that assigned QMS processes are compliant to all applicable regulatory requirements medical device (Class I EMA & Class II US) in accordance with MDR 2017/745, ISO13485 and FDA cGMP regulations 21 CFR part 820 for EMEA
• Review the implementation and efficiency of QMS processes within the organization working together with stakeholders, especially R&D with focus on design assurance
• Quality representative in design and development assignments and projects to ensure quality and regulatory compliance
• Function as process responsible / process owner for assigned QMS processes
• Support quality reporting, KPI collection and assessment.
• Act as internal auditor
Apply through this link:
https://permobil.csod.com/ux/ats/careersite/5/home/requisition/1881?c=permobil You can also apply on Permobils website at "Career", your application must contain a CV and personal letter.
Your profile
Your background
• Master degree or Bachelors degree preferably in science and engineering.
• Good knowledge of quality systems, quality assurance and regulatory standards within the Medical Device or Pharma industry (preferably within Medical Device), based on some years' experience in a relevant role
• Good knowledge of risk management, ISO 14971:2019 meritorious
• Fluent in English both oral and written , other languages 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 great leadership and having the ability to develop efficient processes.
More information
Please apply via our career page as soon as possible. We will conduct selection continuously so send us your application today! Apply through this link:
https://permobil.csod.com/ux/ats/careersite/5/home/requisition/1881?c=permobil For more information about the position, please contact Daniel Decker at +46790661020
For information about the recruitment process please contact HR BP Maria Myrén at
maria.myren@permobil.comFour unions related question, please send an email to
unionen@permobil.comAbout the organisation
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/ Ersättning Fast lön
Så ansöker du Sista dag att ansöka är 2023-05-15
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "68442".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Körkort För detta jobb krävs körkort.
Arbetsplats Poolia Umeå AB
Jobbnummer 7696069
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