POSITION SUMMARY: Assist in the support of ALung’s inspection processes including incoming, in-process and final inspection. As a member of the Quality team, the Inspection Technician will support quality, manufacturing and sourcing in the development efforts for respiratory support devices.
Perform visual and dimensional inspections of incoming, in-process and finished components, subassemblies, and products.
Provide input for inspection methods and improvements related to the job.
Maintains and manages the NCMR and Rework processes and records.
Updates metrics for incoming, NCMR and Reworks.
Leads Material Review Board meetings for Non-Conforming Materials.
Assist quality, manufacturing and engineering in investigations of process related quality issues.
Write Non-Conforming Materials Reports when required and be familiar with the process of quarantining products that have been rejected by QA.
Provide samples and communication to QA, manufacturing and engineering concerning quality issues when required.
Maintains and manages the inhouse Calibration and PM system.
Use statistical analysis to determine correct sampling plan/frequency to insure valid inspection plans.
Maintains information systems.
Completes accurate records (on paper and electronic data) in order to provide excellent results. Also completes accurate records for continuous improvement. These records include inspection reports, training records, equipment maintenance logs, continuous improvement initiatives, and corrective action reports.
Understands the function and purpose of these records. Completes records neatly with a goal for 100% accuracy of content and spelling.
Organizes work and storage areas for efficient workflow and to showcase the quality of work in the lab.
Other duties as assigned.
Candidate will provide budgetary inputs to VP of Regulatory Affairs and Quality.
Experience and ability to work within a clean room environment for extended periods of time to perform in process and material inspections.
Candidate must exhibit manual dexterity – working with small parts, microscopes, eye loops, needles and tweezers.
CMM experience preferred.
Candidate is expected to use sound independent judgment to implement the inspection process for ALung’s incoming materials and supplies.
Ideal candidate will be comfortable and competent with handling information critical to maintaining the quality of the materials utilized in ALung’s production.
Decisions and actions of candidate will directly impact the cost and methodology of the manufacturing processes for ALung’s medical devices.
Candidates will have a strong attention to detail and the ability to work with shifting priorities.
Associates Degree or equivalent applicable work experience, required. Preference to certifications in precision inspection and other related disciplines.
Three or more years of experience in inspection of biotechnical devices and their components, including first article inspection and gauge calibration. Experience with comparators, micrometer, caliper, dial gauges, and height gauges is a must.
Must be familiar with ISO-13485 or similar Quality System.
Familiar with FDA regulations, which is used to perform job duties.
Strong analytical, oral communication and writing skills required.
The candidate must be proficient with MS Outlook, Excel, Quality/Production Engineering, and GD&T (General, Dimensioning, and Tolerance) able to read, interpret, and analyze blueprints. Must be able to communicate ideas and information clearly, effectively, and frequently (oral and/or written) within program team and throughout the company.
Ability to work within a regulated environment and follow appropriate procedures and standards.
Previous exposure to statistical data analysis.
Candidate must be able to lift materials up to 25 lbs on a daily basis as part of their responsibilities.
There is only occasional travel (< 5%) required for this position.
ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere V...entures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.
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