Quality Systems Specialist III

Organization: 
Cepheid - US
Job Location: 
Sunnyvale, CA
Job Description: 

This position is responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485:2003 (ISO). Specifically, functions including record review, product release and document control fall under this position.

- Review of records and documents, for completeness and compliance with QSR and ISO requirements.
- Review of batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
- Generation of standard operating procedures to define and improve quality system functions.
- Support of the Material Review Board, for the assessment and disposition of non conforming materials.
- Support of the Agile electronic documentation process as needed.
- Lead and participate in interdepartmental initiatives for continuous improvement.
- Provide companywide training on general quality principles and specific procedural requirements.
- Facilitate process improvement within other department, through the use of training, coaching, and team participation.
- Support of the corrective action program, with hands on ownership for investigation and resolution of issues.
- Participate in the internal auditor program.

- A minimum of a Bachelor's degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment.
- A minimum of 4-6 years of relevant experience.
- Excellent verbal and written communication skills are a must; in group or one-on-one settings.
- Computer skills essential, 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.
- Ability to perform routine statistical applications.
- Understanding of SPC techniques.
- Experience in compiling data to support metrics analyzing current process.
- Understanding the Design of Experiments, root cause analysis, failure analysis, six sigma and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting.

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