Quality Specialist - IVD

Role and Responsibilities: Under the direction of the Vice President, Quality Assurance and Regulatory Affairs:

* Develops written policies and procedures required for establishment of a QSR-compliant Quality System.
* Works with Management and Staff to develop practical solutions to achieve regulatory compliance.
* Trains Management and Staff on policies and procedures.
* Performs internal audits to assess compliance, and works with Management and Staff to develop practical solutions to achieve compliance.
* Assists in development of Quality Plans.
* Maintains all records and documents within the Quality System.
* Assures all products, processes and systems comply with DxTerity policies, procedures and specifications.
* Performs supplier qualification, supplier audits and monitors supplier quality.
* As a member of project teams, participates in the planning and execution of required validations
* Oversees CAPA program effectiveness
* Participates as assigned as a Quality representative on project teams
* Assists in the development and monitoring of quality metrics.

* ASQ Certification as Quality Engineer or Quality Auditor or equivalent.
* Experience with product design controls during development of nucleic acid-based assays for disease detection and diagnosis or development of pharmaceutical products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor's office market.
* Experience in planning, coordinating and documenting controlled studies, including protocols.

Desired:

* Experience as an auditor for Federal and State inspections, ISO/ European Directives/ Notified Bodies, and/or U.S. FDA Quality System Regulatory Compliance inspections.
* Technical knowledge of molecular biology and genetic testing laboratory practices (CLIA, ASR, IVD).
* Training and experience in basic statistical analysis tools, Design of Experiments (DOE) and Six Sigma methodologies preferred.
* Knowledge of safety precautions required for working with blood borne pathogens at Biosafety Level 1 and 2.
To find out more about Real please visit www.realstaffing.com