Quality Systems Specialist
A molecular diagnostics company in Sunnyvale, CA is seeking a Quality Systems Specialist to join their team!
The Quality Systems Specialist is responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 (ISO). Specifically, functions including support of manufacturing and process improvement, record review, product release and document control fall under this position.
- Review records and documents, for completeness and compliance with QSR and ISO requirements.
- Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
- Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
- Support interdepartmental initiatives for continuous improvement.
- Partner with departments to promote improvements, through the use of training and coaching.
- Support the corrective action program in the investigation and resolution of issues.
- Support the eDMS electronic documentation process, as needed.
- Participate in the internal auditor program, as needed
Bachelor’s degree with 0-2 years of related work 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.
Experience in DNA diagnostics or other medical devices
Associate degree a plus.
Work related experience in a regulated environment
Previous experience reviewing batch record a plus.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.