Candidate Opportunities

Quality Control Specialist - 2018-029

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Location
Lake County, IL
Job Type
Direct Hire
Date
Nov 12, 2018
Job ID
2618493
Long standing company, known for long tenured employees; great growth potential.
 
Responsible for assisting in the implementation, maintenance, improvement, and/or creation of Quality Control processes and associated procedures/records. May include the execution of or support of the following processes: Non-Conformance Reports, Material Review Board meetings and dispositions, Device History Records (DHR), Labeling Review and Revision, Incoming Inspection and/or Product Release, as well as maintenance of and management of instrument Calibration and Maintenance Records. 
 
REQUIREMENTS AND RESPONSIBILITIES:
  • Compliance with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820 and ISO 13485.
  • Support the implementation, maintenance, and improvement of Quality Control records and processes: Non-Conformance Reports, Material Review Board meetings and dispositions, Device History Records, Revision and maintenance of Labeling Inspection procedures, Incoming Inspection and / or Product Release, Instrument Calibration and Machine Maintenance Records
  • Supports complaints and recall processes; assists in the retrieval, evaluation, and disposition of returned devices
  • As required, support inspection activities per procedure as directed by the QC Supervisor. 
  • Comply with regulatory requirements using Good Documentation Practices (GDP).
  • Perform and/or participate in corrective & preventative action (CAPA) investigations, as needed.
  • Cross functional; supporting other departments such as Sales, Manufacturing, Regulatory Affairs and Administration.
  • Aware of and compliance with 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 
  • B.S. Degree preferred; or 3+ years appropriate experience necessary.
  • Working knowledge of 21 CFR 820 and preferably 21 CFR 7, 806, and 810
  • Manufacturing and/or Quality Control Background