Candidate Opportunities

Quality Inspector - 2018-017

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Location
Lake County, IL
Job Type
Direct Hire
Date
Nov 12, 2018
Job ID
2599671
HOT! Well established company, known for long tenured employees; great growth potential.
 
Hold primary responsibility for incoming, in-process, and final inspection of components, sub-assemblies, and finished goods.
 
REQUIREMENTS AND RESPONSIBILITIES:
  • Compliance with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation 21 CFR 820.
  • Comply with regulatory requirements using Good Documentation Practices – GDP.
  • Ensure training status is current for applicable procedures prior to execution of duties.
  • Perform and Document inspection activities per leased procedures to ensure product and process conformance.
  • Escalate awareness of patterns of product failures or process deviations to proactively reduce process errors and improve regulatory compliance.
  • Use a variety of measurement equipment and obtain repetitive results. The Metrology equipment to be used will include micrometers, calipers, rulers, gauge blocks, optical comparator, automated measuring equipment, electrical instruments and various hand tools.
  • Support any quality related activities as required.
  • Work overtime as needed to support assigned duties. 
Additional Responsibilities:
  • Coordinate calibration program schedule, vendor interface and data entry, as needed.
  • Interpret geometric tolerance and use same in inspection planning.
  • Participate in developing inspection procedures and work instructions.
  • Perform inspections per the procedures and complete inspection reports accurately.
  • Complete non-conformance reports and execute containment actions as needed.
  • Troubleshoot inspectional non-conformities and communicate issues to manufacturing, purchasing and vendors.
  • Review Certificate of Analysis and Conformance or other submitted quality data to ensure compliance to specifications.
  • Aware of and comply with the Corporate Quality Manual and applicable laws and regulations as they apply to this job type/position.
  • Complete all planned Quality & Compliance training within the defined deadlines.
Qualifications:
  • High school diploma with preference for vocational studies, such as machine shop, or computerized mechanical drawings.
  • Intermediate computer skills preferred; familiarity with MS Office suite of products.
  • Legible handwriting.
  • Experience in a medical device manufacturing environment operating under regulations from FDA QSR, ISO 13485, etc.
  • Able to take instructions and work independently and proactively.
  • 2-3 years experience in a quality control and quality assurance role in the medical device industry.
  • Strong written and oral communication skills.
  • Experience with and understanding of cross-cultural difference and the ability to work within this environment is crucial for successful employment.