Quality Assurance Inspector
Company: SonaCare Medical, LLC
Location: Indianapolis
Posted on: February 24, 2021
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Job Description:
About SonaCare MedicalSonaCare Medical is a world leader in
minimally invasive focused ultrasound (HIFU) technologies. SonaCare
Medical is committed to developing focused ultrasound related
technologies that support precise and innovative procedures for the
treatment of a range of medical conditions. SonaCare Medical, with
its subsidiary Focus Surgery, Inc., designs and manufactures
medical devices, including the following: Sonablate--, which has
510(K) clearance in the U.S. under a De Novo regulatory
classification; Sonablate-- 500, which has CE Marking and has
obtained regulatory authorization in more than 49 countries outside
the U.S.; Sonatherm-- laparoscopic HIFU surgical ablation system,
which has 510(K) clearance in the U.S., has CE Marking and has
obtained regulatory authorization in more than 30 countries outside
the U.S.SummaryThe Quality Assurance Inspector will be involved in
various facets of the material process including, but not limited
to the inspection of a variety of mechanical and electrical
components, subassemblies, subsystems for Incoming Inspection,
First Article Inspection and other activities as assigned.Duties
will fluctuate on a daily basis.Duties and ResponsibilitiesRead,
understand and follow standard process instructions and/or
drawings.Inspect purchased parts, assemblies, accessories, and
materials and examine all items fordefects in materials, work, and
damage occurring in transit.Compares quantity and part number of
items received with procurement data and otherspecifications to
ensure completeness and accuracy of acceptance criteria.Enter data
on material inspected into computer systems used for testing or
inspecting parts.Inspect for conformance to specifications, using
precision measuring instruments and devicesaswell as conformance to
cosmetic requirements.Use precision measuring instruments and
devices for dimensional accuracy, fit, alignment, andfunctional
operation, according to drawings, work instructions, company
standards, and otherspecifications.Use electrical test equipment
and instruments to measure functional operation, according
todrawings, electrical schematics, prints, work instructions,
company standards, and otherspecifications.Approve or reject items,
and record inspection and disposition information.Ensure serial/
lot number traceability is maintained.Initiate nonconformance
process as needed.Participate in the review and editing of
inspection procedures.Follow and meet all safety and quality
procedures and standards.All other duties, as
assignedQualifications/SpecificationsHigh School Diploma or
equivalent.Previous experience in the medical device industry, or
other regulated industry, preferred.2+ years Quality Control
experience in Receiving Inspection,preferred.Experience utilizing
IPC Class III standards for soldering and inspection of circuit
boardassemblies.Experience soldering to IPC Class III standards,
preferred.Must have good written and verbal communication
skills.Good arithmetic skills,required.Mechanical aptitude,
desired.Working knowledge of measurement and electrical test
equipment and instruments.Strong attention to detail.General
proficiency of Microsoft Excel, Microsoft Word, Outlook.The
physical demands described here are representative of those that
must be met by anemployee to successfully perform the essential
functions of this job. While performing the dutiesof this job, the
employee is regularly required to stand; walk, and sit for extended
periods of time,as well as lift heavy objects.
Keywords: SonaCare Medical, LLC, Indianapolis , Quality Assurance Inspector, Other , Indianapolis, Indiana
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