Assessor/Auditor - IVD Medical Devices
Do you consider yourself knowledgeable on manufacturing/design and quality management processes within the medical device industry?
Do you enjoy travel, both in and out of your home country?
Do you want to bring your expertise to a notified body?
Our assessors in our medical device team do just that. You’d be joining the 13485 Assessment Delivery team and regularly travel across the EMEA region (Europe, Middle East and Africa) to help medical device manufacturers improve their performance. You’d do this by assessing their organisation, processes and product against the relevant medical device standards, directives and regulations.
You’d be joining a growing team of diverse individuals from engineering, science and biotechnology backgrounds and have the opportunity to share your skills and interest with these professionals as well as 24 of the world’s top 25 medical device manufacturers.
Your career as a BSI medical device assessor will be challenging, rewarding and exciting. You’ll assess start-up companies, large multinational corporations and get to discover how different each standard, product and system is.
As the regulatory environment changes we want people who are passionate about providing excellent customer service and understand how vital this role is to the delivery of trusted and safe medical devices to the market.
If you do not hold a degree, but hold other relevant further educational qualifications such as HND/HNC then a minimum of 10 years recent and relevant work experience (outside of academics) in the medical device area outlined is required.
You will also need a minimum of 2 years’ experience in the area of quality management e.g. working within a certified QMS (Quality Management System) such as ISO 13485 or ISO 9001.
- You’ll have proven experience in the area of IVD (In Vitro Diagnostic) devices
- Be confident, able to communicate with internal and external customers at any level, from the manufacturing workshop up to the top management/CEO.
- You’ll be driven, passionate and have a methodical approach to your work
- You’ll have excellent interpersonal skills as well as strong verbal and written communication skills
- You’ll be capable of working independently, be self-sufficient, organised and capable of making good decisions quickly and effectively
- Be capable of delivering work to strict deadlines
For you to become a medical device assessor you must have:
- Obtained a degree (Bachelors, Masters, PhD or equivalent) relevant to the medical device area you wish to work in alongside a minimum of 4 years continuous and recent work experience in the medical devices outlined above.
- Work experience or “hands on experience” is qualified as the design, design transfer, manufacture, research and development (outside of academics) and sometimes service, installation and maintenance of medical devices.
- If you do not hold a degree, but hold other relevant further educational qualifications such as HND/HNC then a minimum of 10 years recent and relevant work experience (outside of academics) in the medical device area outlined is required.
- You will also need a minimum of 2 years’ experience in the area of quality management e.g. working within a certified QMS (Quality Management System) such as ISO 13485 or ISO 9001.
What BSI offer:
Competitive starting salary with a vast range of flexible benefits that you tailor to suit you.
We’ll invest from you from the beginning and provide you with all the training to become a medical device assessor.
This includes current Medical Device Directives and the forthcoming regulations, MDSAP and Lead Auditor training (if not already qualified).
You’ll also embark on a comprehensive induction into the role.
Come and join the power of BSI.
BSI (British Standards Institution) has over 81,000 clients in 182 countries, and is an organization whose standards inspire excellence across the globe. We enable our clients to be, innovative, trusted and agile.