Quality Assurance Manager with marketing focus to Permobil

Quality Assurance Manager with marketing focus to Permobil

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. Apply if you feel that this could be something for you!

About Permobil
Permobils 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 & Responsibilities
As a Quality assurance manager focusing on product development, you will work to support management of the regional QMS and especially the processes supporting marketing and sales organizations. 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, 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 supporting marketing and sales.
• 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

Required 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 verbal and written in English. It is meritorious to be fluent in Swedish both oral and written. In this role it is important to have the natural characteristics of great leadership and having the ability to develop efficient processes.

Interfacing with all departments within EMEA, other sites, regions and global functions within Permobil Group as well as competent authorities, notified bodies etc.

Selection 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. Mark your application with reference number: Pqm0721

Contact person: Carin Helander

Please note that we do not accept applications via email / e-mail.

we take you further

QA 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 Marketing, Launch, Market Requirements Specifications, MRS, Clinical training material

Stockholm (also remote)

Life Science

Typ av tjänst


Sök tjänsten genom att klicka här >>

Lediga jobb

Ekonomiassistent inom kund- och leverantörsreskontra >>

Löneadministratör / Lönekonsult >>

Business Controller / Financial Controller >>

Interima konsulter inom Ekonomi >>

HR Konsulter till framtida uppdrag >>

Quality Assurance / QA för framtida uppdrag inom läkemedelsindustrin Stockholm >>

Underkonsult inom Redovisning >>

Laboratorieingenjör inom Mikrobiologi och Molekylärbiologi till framtida uppdrag i Stockholm >>

Scientist / Laboratorieingenjör till kommande uppdrag i Stockholm >>

Processoperatörer till framtida uppdrag inom Life Science, Stockholm >>

Laboratorieingenjör till QC med erfarenhet av cellodling >>

Erfaren Redovisningsekonom till årsbokslut >>

Redovisningsekonom till byrå >>

Laboratorietekniker för kunds räkning i Stockholm / Uppsala >>

Senior Redovisningsekonom till koncern som är börsnoterad i Stockholm >>

Rekryteringskonsult / Rekryteringsspecialist / Talent Acquisition specialist till affärsområdet Life Science och HR på Academic Resource, Stockholm city >>

Laboratorietekniker för framtida uppdrag i Uppsala >>

Ekonomiassistent till stort växande företag >>

QA för kommande uppdrag inom Life Science i Uppsala >>

Erfaren Processoperatör till Uppsala sökes! >>

Redovisningsekonom till bolag i city >>

Nyexaminerade ingenjörer inom biomedicin, BMA, kemi eller biologi till kunder i Stockholm / Uppsala >>

Laboratorietekniker till Atlas Antibodies >>

Quality Assurance Manager with design assurance focus to Permobil >>

Anläggningstekniker / underhållsingenjör till läkemedelsföretag, Stockholm >>

Quality Assurance Manager with marketing focus to Permobil >>

Redovisningsekonom till konsultuppdrag >>

Senior redovisningsekonom till företag i centrala Stockholm >>

Löneadministratör till ett Life Science bolag i Uppsala >>

Training Developer / Producer to Cytiva in Uppsala >>

Driven och engagerad HR-generalist till Recipharm >>

Orderplockare / Lagermedarbetare till Atlas Antibodies i Bromma >>

Tillverkningstekniker med truck- och traverslicens till Uppsala >>

Konsultuppdrag som Laboratorieassistent på Cytiva i Uppsala >>

Biomedicinsk analytiker till QC inom bioteknik i Uppsala >>

Laboratorietekniker/ingenjör med titel Laboratoriespecialist till QC hos vår kund i Uppsala >>

Provtagare / Laboratorieassistent / Laboratorietekniker till Octapharma >>

Laboratorieingenjör med inriktning Mikrobiologi till Eurofins i Uppsala >>

Underhållstekniker / Maskinmontör / Automationstekniker / Maskintekniker till ett välkänt läkemedelsföretag i Stockholm >>

Vi söker en energifylld och positiv Ekonomiassistent till Northpower Stålhallar >>

Processoperatör / Maskinoperatör / Operatör till läkemedelsföretag i Stockholm >>

Redovisningsekonom till ett bolag i Lund >>

Serviceingenjör till det laboratorietekniska företaget NORSK LABEX AS >>

Serviceingeniør for laboratorieteknologiselskapet NORSK LABEX AS >>