Job ID: #8935

Quality Assurance Manager, CLIA

Waltham, MA
Science Science
QA / QC

 

Responsibilities of the Quality Assurance Manager, CLIA:

  • Lead and support development, implementation, and enhancements of the quality management system (QMS) pertaining to international and US regulatory guidelines
  • Ensure that QMS processes are developed and actively monitored for reliability and effectiveness
  • Manage the implementation and maintenance of SOPs and other documents.
  • Aide in troubleshooting and investigations of QMS
  • Work cross functionally to ensure internal and external customers are integrated with business and technical needs
  • Ensure compliance with CLIA standards
  • Train and mentor ongoing compliance monitoring for lab quality systems
  • Lead internal and external inspections
  • Assist in quality assurance related to the clinical operations
  • Other quality related duties as assigned

Requirements of the Quality Assurance Manager, CLIA:

  • BS/MS degree in a life science related discipline
  • 5+ years of quality management experience preferably in IVD or molecular biology setting
  • Must have previous experience with CLIA regulations and standards
  • Experience in developing and maintaining QMS
  • Experience with ISO audits and FDA inspections
  • Experience in design control, verification and validation with cross-functional team
  • Ability to evaluate and troubleshoot problems in relation to QMS
  • Strong management and leadership skills with ability to mentor and train others on QMS

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    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.