Cleaning & Disinfection Verification Engineer
Randstad is looking for a Cleaning and Disinfection Verification Engineer for an opportunity in the Pittsburgh area
Description - Seeking a Verification and Validation (V&V) Engineer. The selected candidate will work under direct supervision of the V&V Lead to produce clear and concise V&V documents for medical devices. Focus will be assessing and testing cleaning and disinfection (C&D) methods of medical devices for compliance to International Standards and FDA Guidance. Additional responsibilities of testing products at the system level.
location: Monroeville, Pennsylvania
job type: Contract
salary: $25 - 30 per hour
work hours: 8am to 5pm
Job duties include, but are not limited to:
- Work with a team to assess new or changed C&D methods for products
o Identify/generate validation test protocols
o Hold formal technical reviews to determine methods, sample sizes, inoculation points, treatment cycle counts
o Prepare test sample sets for external labs (validation testing) and internal labs (performance testing)
o Monitor test progress to provide status updates during project meetings
o Generate test reports
- Manage C&D testing with outside test labs.
o Get quotations
o Write POs
o Prepare samples for testing
o Approve C&D protocols
- Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
- Develop V&V test procedures and test reports.
- Provide weekly project status reports.
- Prioritize project tasks to complete on schedule while maintaining quality of work.
- Work in a team environment.
- Work on multiple, concurrent projects.
skills: Working knowledge of the following International Standards and Guidance Documents preferred:
- FDA Guidance for Industry and FDA Staff, March 17, 2015 - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- CDC HICPAC Guideline, 2008 - Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
- AAMI TIR12:2010 - Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities, A Guide for Device Manufacturers
- AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- ISO 14698-1:2003 - Cleanrooms and Associated Controlled Environments, Part 1: Bio contamination Control - General Principles and Methods
- ISO 15883-1:2014 - Washer-disinfectors, General Requirements, terms and definitions and tests.
- Spectaris Guideline
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.