Manufacturing/Quality Engineer (Medical Device Auditor) - West Coast
Company: BSI Group
Location: Seattle
Posted on: January 27, 2023
Job Description:
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, -only -candidates with
Bachelor's degrees in -engineering, 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 least -two years in the area of quality management
-(experience working in an organization governed by regulations and
standards)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.
Keywords: BSI Group, Seattle , Manufacturing/Quality Engineer (Medical Device Auditor) - West Coast, Accounting, Auditing , Seattle, Washington
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