Quality Assurance Manager with design assurance focus to…

Firma: Academic Resource
Job-Typ: Vollzeit
Have you been looking for an opportunity where you can be a part of an international Med Tech company that enables their clients to express themselves, to be seen as the people they really are and to take part in a world around them? Academic Resource is now recruiting one Quality Assurance Manager for Permobil, an international Med Tech company on a growth journey with headquarters in Sweden. We are looking for someone with the ability to travel on a monthly basis. In this position there is possibility to work remotely from Sweden, Denmark, Holland or Italy. Apply if you feel that this could be something for you!About PermobilPermobil’s products include power wheelchairs, manual wheelchairs and seating solutions. Their products are sold in more than 70 countries and they have more than 1 600 employees in 17 countries. Their headquarters is located in Sweden and they have production sites in Sweden, USA and China. Since 2013, the company is owned by Patricia Industries, a subsidiary of Investor.To stand up for the users rights and provide the best possible solutions to enhance their quality of life is their strategy. Past, present and future.Authority & ResponsibilitiesAs a Quality assurance manager focusing on product development, you will support management of the regional QMS as well as R&D and design assurance. 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 (incl design and technical docs), participate in and approve risk assessments, and records such as eg CAPAs, 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. 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
  • 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
  • Function as process responsible / process owner for assigned QMS processes
  • Support quality reporting, KPI collection and assessment.
  • Support Software Validation efforts as QA for systems within assigned areas (including GAMP and 21 CRF part 11)
  • Act as internal auditor
QualificationsRequired Knowledge and Experience:
  • 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)
  • At least 5 years of working experience
  • Previous experience of ensuring 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 (meritorious)
  • Good knowledge of risk management (ISO 14971:2019)
  • Good knowledge of software validation (GAMP and 21 CRF part 11)
  • 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 great leadership and having the ability to develop efficient processes.Contacts/CooperationInterfacing with all departments within EMEA, other sites, regions and global functions within Permobil Group as well as competent authorities, notified bodies etc.ApplicationSelection and interviews will be ongoing. The position may be filled before the last day of application therefore we recommend that you apply as soon as possible. Click on "Sök tjänsten genom att klicka här" to aply. Mark your application with reference number: Pqd0721Contact person: Carin note that we do not accept applications via email / e-mail.we take you furtherKeywordsQA Quality Quality Assurance QAM Manager Quality Assurance Manager Med Tech Medical Device Regulatory Affairs Leader kvalitet regulatorisk audits internal audits documentation Design Control Complaint handling CAPA deviation handling Validation engineer Process Engineer Medicin Teknik Life Science QMS Risk Management, Design Assurance, Regulatory Compliance, Quality EngineerRegionSweden (possible to work remotely from Sweden, Denmark, Holland or Italy)

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