Overview
Perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices.
Perform review of Device History Records for release of finished goods.
Responsibilities
- Perform inspections of purchased parts, subassemblies or finished company products according to well defined criteria using standard physical, mechanical and / or electrical measurements.
- Rework or reject subassemblies or finished products as required.
- Conduct and document process and system audits using written procedures as audit standards.
- Accurately document the results of the inspections and testing.
- Maintain all controlled document files and test records in a timely and accurate manner.
- Coordinate calibration of all test equipment and fixtures
- Monitor critical equipment and instrumentation to ensure proper operation and calibration.
- Participate in the construction and / or revision of SOPs for the inspection function.
- Assist in the writing and updating inspection procedures, protocol and checklists.
- Evaluate problems and make initial recommendations for possible corrective action to supervise.
- Work with production management and Quality Assurance to provide feedback to assemblers regarding accuracy of assembly procedures.
- Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices
- Perform other duties as assigned by supervisor.
- Position will require you to be working onsite at 100% and requires proof that the applicant is fully vaccinated against COVID-19, subject to applicable law
Qualifications
- Mechanical aptitude desired
- Working knowledge of measurement instruments.
Education :
High School Diploma or equivalent
Experience
2+ years Quality Control experience with Medical Device Inspection is preferred
Compensation :
$22.60- $37.50 per hour
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