Cepheid Senior Program Manager, Quality Operations in Sunnyvale, California
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The primary responsibility of this position is to assure conformance to established regulatory requirements and standards through effective implementation of Quality Management System principles and processes. Further responsibilities entail/include managing projects on a site/global level, focusing on compliance and continuous improvement with cross-functional departments, sites, suppliers and experts within and outside Cepheid. This position also entails/includes directing and/or supporting the Quality Management Processes including but not limited to Supplier Quality Management, Supplier Audits, Corrective and Preventive Action and Validation in order to communicate and implement Cepheid Quality Objectives.
Managing corporate supplier quality systems projects for the development and implementation of processes, procedures and instruction to sustain and improve the Supplier Quality Management System
Supporting top management in the strategic planning of quality systems strategies and objectives
Managing cross-functional and cross-divisional teams in the development and implementation of corporate quality systems strategies and objectives.
Managing corporate quality systems initiatives for the development & implementation of harmonized supplier quality systems, best practices across the organization
Identifying and solving continuous improvement opportunities for the improvement and increased efficiency of Cepheid’s quality systems
Identifying and solving product, system and process problems. Supporting various groups as needed for conducting audits and assessments of internal processes and suppliers manufacturing sites, CAPA etc.
- Bachelor’s degree or equivalent education/experience, science and/or engineering major preferred.
Minimum of 10 years of experience in quality department or quality management field. Process improvement skills, a plus (i.e., 6 Sigma/Lean).
Knowledge in acquisition and implementation of quality management systems such as ISO9001, ISO/TS 16949, AS9100, and ISO 13485.
QSA Certified Lead Auditor preferred
PMP Certified preferred
Traveled to multiple sites for coordination of CAPA, internal audits and documentation.
Cepheid is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Over a decade ago, Cepheid set the standard for innovation in automated molecular diagnostics with our first system and we’ve never looked back. And now, even with the largest installed base of any molecular platform, Cepheid is constantly innovating and evolving our capabilities. Our technology has been heralded as game-changing by healthcare leaders world-wide. We envision a better way for clinical institutions of any size, from small medical clinics to high-volume reference laboratories and major hospitals, to access the power of molecular diagnostics. Our GeneXpert® System delivers fast, scalable, and accurate diagnostic results while our expanding Xpert® test menu spans multiple clinical applications such as healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology. Make a difference in healthcare and join us on this mission! For more details, please visit us at www.cepheid.com at http://www.cepheid.com/us/ .