• Job Description

  Req#: JR0005066

  Great that you're thinking about a career with BSI!

  QMS Auditor - Medical Devices

  Location: we have openings in France (Software as a Medical Device & Ortho/Metals/Plastics) & Italy (Ortho/Metals/Plastics). This job includes 70-75% travel within EIMEA

  Please, attach your CV in English

  About BSI

  BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.

  Our Medical Devices team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands and United Kingdom and is an accredited ISO 13485 Certification Body recognised in many global markets.

  Due to the growth of the QMS team, we are looking for QMS Auditors who are client centric and want to drive the importance about patient safety, and are excited by the opportunity to work across the EMEA region with medical device manufacturers.

  To be a successful QMS Auditor, you'll need:

  - At least 4 years experience working in the medical devices industry being individually responsible for one or more of the following:

  · R&D (Research & Development)

  · Design/design development

  · Service, maintenance and/or testing

  · Manufacture/production engineering

  - At least 2 years experience in Quality Management Systems (e.g. ISO 9001/ ISO 13485) and understanding of relevant safety standards.

  - STEM BSc equivalent or higher

  You'd be given full training to ensure your success as an auditor:

  · ISO 13485 Lead Auditor Course

  · MDSAP (Medical Device Single Audit Programme)

  · MDR/IVDR Regulation Training

  We're looking for expertise across a variety of medical devices. We welcome expertise across various device types, but some examples are listed below:

  · IVD (invitro diagnostics) instrumentation and/or reagents

  · Active devices: X-rays, Heart Lung machines, Defibrillators, MRI Scanners

  · Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Implantable infusion pumps

  · Orthopaedics - spinal implants, bone/dental cements, cartilage and soft tissue repair

  · Wound and skin care - dressings, foams, gels

  Click here to view the full range of technologies we cover: Medical Device Technologies | BSI (bsigroup.com)

  Do you believe the world deserves excellence?

  We offer a competitive annual salary and bonus eligibility, comprehensive training programme, career pathways and a wide range of flexible benefits that you can tailor to suit your lifestyle depending on your location.

  #LI-LH1

  #LI-onsite

  Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

  BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

• About the company

  BSI is your business improvement partner. We have shaped best practice for over 100 years, helping organizations around the world embed excellence, build competence and capability for sustainable growth.

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