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

British Standards Institution (BSI) is hiring a Manufacturing or Quality Engineer who is interested in a career as a Medical Device Auditor.

As a Medical Device Auditor, you'll travel to medical device manufacturers across the United States to help implement and ensure compliance across the largest organizations in the world. You'll 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.

Job Description/Expectations:

In the first six months of being a Medical Device Auditor you can expect to:

• Be provided training/certifications in all the leading regulatory schemes associated with medical device quality management system compliance - ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Program) and MDD/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 the US and remotely from your home office (50% onsite, 50% remote)

In a typical week after being fully trained you'll:

• Conduct audits on site or remotely

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

• You'll also continue your development of MDR and be an advocate for the ISO 13485 Delivery Team.

Education/ Qualifications:

• Due to strict regulatory requirements,onlycandidates with Bachelor's degrees inengineering, computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics, will be considered for this role

• A minimum of four years of full-time hands-on (R&D, manufacturing, and/or testing) work experience in the field of medical devices or related sectors

  • Desired expertise in one of more of the following technologies: Vascular (stents, valves, neurovascular, catheters), Active Devices (x-ray machines, software, patient monitors), Active Implantable (pacemakers, defibrillators), Orthopedics (hip, knee, spine, joint implants), metals, ceramics, and plastics fabrication, semi-conductor fabrication, imaging

• At leasttwo years in the area of quality management(experience working in an organization governed by regulations and standards)