Candidate Opportunities

Reprocessing and Validation Specialist - 2018-028

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Location
Lake County, IL
Job Type
Direct Hire
Date
Nov 12, 2018
Job ID
2618489
Long standing company, known for long tenured employees; great growth potential.
 
POSITION DESCRIPTION:
In compliance with all applicable regulatory requirements, initiate and lead all activities relating to device and/or instrument reprocessing. And, as directed, support the development and execution of manufacturing process validations and equipment qualifications.
 
REQUIREMENTS AND RESPONSIBILITIES:
  • Understanding and implementation of all applicable regulatory requirements relating to the reprocessing, reuse, and labeling of medical devices with specific focus on 21 CFR 801, 820.
  • Experience developing and executing process validations. 
  • Deep understanding of the implementation of the latest revision of the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling FDA Guidance Document.
  • Familiarity with the steps required for preparing a device for marketing within the US.
  • Primary contact for ensuring on-market products have valid and approved cleaning, disinfection, and sterilization methods for reprocessing.
  • Owner of corporate customer support communications email.
  • Reviewer of website and other labeling for regulatory content oversight.
  • Maintain awareness of relevant product and regulatory standards and recommend actions to ensure compliance with requirements.
  • Use experience and judgment to pragmatically implement and comply with all regulatory requirements. 
  • Coordinate development of approved cleaning and sterilization processes with Corporate for USA/FDA market requirements.
  • Work closely with the Product Managers, quality, and regulatory to ensure adequate instructions & IFUs are developed, approved and provided to end customers and assist end customers in reprocessing related compliance issues.
  • Oversee and maintain compliance for all reprocessing activities executed within the receiving area.
  • Manage external sterilization services including approval of service providers and facilitate validation activities.
  • Assist in audits of sterilization and laboratory service suppliers as needed.
  • Complete all planned Quality & Compliance training within the defined deadlines
  • BS Degree (nursing, biology and\or microbiology required). 
  • Microbiological, biocompatibility, and chemical compatibility test methodologies and validation requirements for reprocessing medical devices.
  • Knowledge and understanding of the various cleaning and sterilization methods employed in hospitals, clinics, and various office practice settings where corporate equipment might be used.
  • ISO and AAMI standards knowledge as it relates to cleaning, sterilizing, and Analytical Labs for reusable medical devices.
  • Practical working knowledge of Industrial Sterilization of single use devices is required.
  • Previous experience in quality systems and an FDA regulated environment is required.