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The Quality System Specialist will be a member of the Quality Assurance team responsible for adminstration of nonconformance process (NCR).
- Administrate the NCR process, Material Review Board and NCR metrics
- Review NCR records and documents for completeness and compliance with QSR, ISO and Cepheid requirements; provide feedback and obtain corrections as needed.
- Generate standard operating procedures to define and improve quality system functions.
- Revise existing documentation and processes to support continuous improvement.
- Lead and participate in interdepartmental initiatives for continuous improvement.
- Provide companywide training on general quality principles and specific procedural requirements.
- Facilitate intradepartmental process improvement through the use of training, coaching, and team participation.
- Support the corrective action program.
- Support external audits.
- Participate in the internal auditor program.
- Participate in other Quality System functions as required to support the achievement of departmental goals.
- Bachelor's degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience
- A minimum of 2-4 years of relevant experience.
- Excellent verbal and written communication skills in group or one-on-one settings.
- Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems, ERP systems.
- Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
- Understanding of general mathematical principles and calculations, at college entry level.
- Experience in compiling data to support metrics analyzing current process.
- Understanding of investigation and root cause analysis.
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