Inspector III, QC – San Diego
Company : Werfen
Country: United States
Location : San Diego, California
Post: Mon, 20 Sep 2021 07:10:27 GMT
Expires: Mon, 18 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Our Passion. Your Results.
Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.
As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.
The QC Inspector III is responsible for the inspection of components and assemblies of a multi-shift medical device manufacturing operation. The QC Inspector III performs incoming material and in-process and final product inspections to ensure items meet specification.
Perform incoming material inspections, including mechanical inspections, with hand held inspection gages as well as visual inspections.
Perform in-process inspections of instrument assembly.
Follow standard operating procedures (SOPs) to perform functional test of electro/mechanical diagnostic medical instruments.
Issue non conformance reports.
Perform inspections of packaged product to ensure completion and accuracy.
Enter test results into computerized material management system.
Review device history records to ensure they are complete and accurate. Perform first article inspections.
Support special projects as assigned by management.
Ensure and maintain compliance with the companys quality system requirements through training and adherence to policies, procedures and processes.
Other duties as assigned.
High school diploma required; additional technical training or schooling strongly preferred.
At least three (3) years previous Quality Control (QC) and/or Quality Assurance (QA) experience; previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
Ability to read mechanical detail drawings, printed circuit board drawings, and parts list.
Previous experience with gages for mechanical inspection micrometer, caliper, depth gage, force gage, gage blocks, dial-indicator, multi-meter, digital thermometer, optical comparator and vision inspection system.
Previous experience/accountability recording inspection results.
Experience with product functional test.
Experience with electronic soldering techniques and visual printed circuit board inspection.
Working knowledge sampling plans.
Knowledge of/practical experience with Quality Systems Regulations (QSR), Good Manufacturing Practices (GMP), and International Organization of Standards (ISO).
Working knowledge of Microsoft Office; knowledge of large Enterprise Resources Planning (ERP) system preferred.
Good written and verbal communication.
Ability to work as part of a team.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or RESUME.
Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
Werfen is a global leader in in vitro diagnostics (IVD) in the specialties of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.
We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.
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