Complaint Analyst California
4/23/2016 1:55 AM

The Complaint Analyst will be a member of the Global Product Support Team to maintain the company's incident reporting (Complaint Handling) system and review of world-wide complaint data. This person will help maintain procedures and policies required to intake, review and approve complaints, while maintaining compliance with applicable Quality System requirements and FDA regulations. Responsib  ...View Job
Production Supervisor, Reagents California
4/16/2016 6:48 AM

Cepheid is looking for a Supervisor for the Reagents Manufacturing group that will oversee the production of all reagents including Beads, Bulk Reagents, Dyes and Secondary Standards. The Supervisor will be responsible for organizing and monitoring work flow for Manufacturings Chemists and Reagents Technicians. • Learns and enforces company safety policies and practices • Maintains safe and cl  ...View Job
Senior Project Manager California
4/16/2016 4:28 AM

The Senior Project Manager will be responsible for planning, coordination, tracking, and successful implementation of multiple medical device, molecular in-vitro diagnostic hardware, software, and system projects and for ensuring Engineering project and program consistency with corporate strategies and goals, product development processes, and quality system and regulatory requirements. Respons  ...View Job
Incoming Inspection Quality Engineer California
4/16/2016 4:22 AM

The Incoming Quality Engineer will support incoming inspection by developing new/improved inspection methods and provide appropriate training to staff. Responsibilities: • Work with the INC Supervisor to help improve the process of incoming inspection to include: o Identify ways to increase inspection productivity by designing and fabricating inspection fixtures, techniques and methods. o W  ...View Job
Software Test Technician California
4/16/2016 3:42 AM

The Software Test Technician will be responsible for performing basic analysis, execution, and review of software test protocols in the Software Quality Assurance department under direct supervision. This person will be member of the Software Quality Assurance team responsible for ensuring that software developed by engineering is robust, functional, and compliant with established protocols/proced  ...View Job
Quality Systems Engineer NPI California
4/16/2016 3:38 AM

The Quality Systems Engineer, NPI, will support quality systems activities related to the development of new assays and reagents. Key responsibilities will include design control and the development of validation master plans in compliance with FDA/ISO regulations. The ideal candidate will have a Quality Engineering background in the IVD/medical device industry and possess a sound understanding of  ...View Job
Software Test Technician California
4/16/2016 2:28 AM

The Software Test Technician will be responsible for performing basic analysis, execution, and review of software test protocols in the Software Quality department, under direct supervision. Software Test Technicians at Cepheid are responsible for the quality of the software that is shipped to customers, used in manufacture of medical devices, used in Cepheid's quality system, and system software   ...View Job
Scientist California
4/4/2016 4:46 PM

The Scientist will perform bench level work focusing on real time PCR and RT-PCR based IVD product development in an FDA-QSR and ISO9001 compliant organization. This is a temporary position for ~ 7 months • Help to optimize real time PCR and RT-PCR assays for the GeneXpert platform based on design input requirements. • Help write verification SOPs and technical reports. • Maintain detailed ex  ...View Job
Senior Manager, CSET (Plastic Injection Molded R&D Engineering) California
3/21/2016 7:42 AM

The Senior Manager, Component Specialist Engineering Team (CSET), is the recognized technical expert of an assigned critical component of Cepheid's product line. This person will lead and manage a team responsible for a variety of specialized engineering and technical duties related to the assigned area of specialization, including: * Part designs and specifications * Mold development and qual  ...View Job
Quality System Specialist II California
3/21/2016 7:39 AM

The Quality System Specialist is responsible for investigating and documenting NCR closure activities and performing risk assessments on NCRs as needed in compliance with the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485:2012 (ISO), the IVD Directive and Canadian Medical Device Regulation (CMDR). Shift is Mon - Fri days. Responsibilities: * In  ...View Job