Quality Systems Specialist
A biotech manufacturing company in Sunnvale, CA is looking for a Quality System Specialist to be responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485. Specifically, functions including support of record review, product release and document control.
- Review records and documents, for completeness and compliance with QSR and ISO requirements.
- Review batch record to support release of NCR raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
- Generate standard operating procedures to define and improve quality system functions.
- Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation report.
- Support the eDMS electronic documentation process as needed.
- Lead and participate in interdepartmental initiatives for continuous improvement.
- Provide company-wide 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 the corrective action program, with hands on ownership for investigation and resolution of issues.
- Participate in the internal auditor program.
Bachelor's Degree in scientific, quality system or a related discipline or, equivalent combination of education and experience to perform at this level.
4 to 6 years of practical experience in a regulated manufacturing environment.
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.
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.
Experience in DNA diagnostics or other medical devices
Certified Quality Engineer, Certified Quality Auditor or similar certification.
For more than thirty 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.