Quality Assurance Inspector

Indianapolis, IN

About SonaCare Medical:

SonaCare 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.

Summary:

The 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 willfluctuate on a daily basis.

Duties and Responsibilities:

Read, 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 assigned.

Qualifications/Specifications:

High School Diploma or equivalent.High 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 boardExperience utilizing IPC Class III standards for soldering and inspection of circuit board assemblies.

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.

 

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