Field Based, South Africa
6 days ago
Auditor Medical Devices - Ortho

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

Auditor Medical Devices (internally known as Client Manager) - Orthopaedics

Location: South Africa - fieldbased, 70%-75% of travel required within EMEA

As a Client Manager in Regulatory Services, you will travel to medical device manufacturers across South Africa and EMEA. You will help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, so they can ensure patient safety and comply with regulatory procedures.

Responsibilities:

In the first six months of being a Client Manager, you will:

Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)

Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across EMEIA and remotely from your home office

In a typical week after being fully trained, you will:

Conduct an audit on site, remotely or hybrid

Write up your reports and liaise with the planning team to manage your audit schedule.

Continue your development of MDR and be an advocate for the ISO 13485 EMEIA Delivery Team.

To be successful in the role, you will have:

A Bachelor's Degree in a STEM area

At least 4 years of full-time work experience in the medical devices-ortho industry. This experience must be within product realization where you have been responsible for either the Design, R&D and/or Manufacturing and/or Servicing/Repair or production engineering

At least 2 years’ experience working in an environment with a Quality Management System established 

Ability to speak and write fluently in English and Dutch

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development with the inclusion of 22-days annual leave, paid sick leave, bank holidays, health insurance, life insurance, retirement fund, short-term disability, long-term disability, paid family responsibility leave, paid maternity leave, paid paternity leave, learning and development opportunities, and a wide range of flexible benefits that you can tailor to suit your lifestyle.  

 Do you believe the world deserves excellence?  

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries.

 

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family! 

  

D&I Policy  

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive. 

If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.  

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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.

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