Auditor - IVD Medical Devices QMS

Auditor IVD Medical Devices (internally known as Client Manager)

Israel - field-based

External Resource, Contractor

About the role

Our QMS Delivery team within Regulatory Services are looking for talented people to join our Medical Device Auditor team. The role involves travelling to various locations to assess quality management systems, supporting patient safety and regulatory compliance. Our audits encompass standards such as ISO 9001 / ISO 13485 and schemes such as MDSAP. We also support conformity assessment activities such as those related to UKCA and CE marking.

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

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

• Conduct an audit on site, remotely or hybrid, working alone or as part of a team
• Write up your reports and liaise with the planning team and delivery manager to manage your clients and audit schedule
• Complete other administrative activities as required

1) To be successful, you need to have a minimum of 4 years hands on experience in one or more IVDs of the following areas:

• research and development
• design or design development;
• servicing, maintenance and or testing;
• manufacturing or production experience.

2) Covering a range of medical devices which could include:

• IVD, Reagents, Instruments, Chemicals, Pharmaceuticals, Drug-Combination

3) Your experience will also include at least 2 years' working with quality management systems.

4) You must have completed a university or technical college degree or equivalent in a related STEM subject (BSc, MSc or PhD) such as: Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical or Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.

Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.