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Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is f... Read More
|Address||904 Caribbean Drive Sunnyvale, CA 94089 USA|
|Holding||No Holding Details|
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Senior Director of Quality Systems
The Senior Director of Quality Systems is a leadership role within the company to ensure continuous improvement of the Cepheid Quality System functions ensuring that we meet our corporate Quality Policy. In addition, this position is responsible for document control, batch record review and product release functions for all products in development and production at Cepheid. This position oversees the development, implementation and maintenance of Quality Systems and activities working with the VP, Regulatory Compliance and Quality Systems.
* Responsible for ensuring the implementation, maintenance and continuous improvement of the Cepheid Sunnyvale quality system meeting both operational quality and regulatory requirements.
* Responsible for CAPA, NCR and audit systems.
* Responsible for preparing and presenting bi-annual Cepheid North America Quality Management Review for senior management.
* Responsible for monthly operational Quality Review Board.
* Responsible for the QA release of all products for the organization.
* Responsible for the document change process used at Cepheid; ensure electronic document management system meets operational quality and regulatory requirements; and ensure adequate training is provided to users.
* Responsible for working with functional areas to establish/update metrics that are reported to upper management that highlights key opportunities for continuous quality improvement.
* Provide QA input to manufacturing, QC, and development processes in order to maintain a GMP compliant organization driving for continuous quality improvement.
* Responsible for ensuring activity management boards are meeting business/SOP requirements and that these metrics are routinely and consistently shared with upper management.
* Identify and suggest functional improvements throughout the organization to further ensure regulatory compliance and constant inspection readiness.
* Ensures budgets, schedules, and department performance requirements are met.
Required Knowledge - Skills - and Abilities:
* Bachelor degree in a Chemistry, Biology, Engineering or related field.
* Past experience in a medical device/diagnostics field required.
* 10+ years experience in Quality Systems in a regulated industry.
* 8+ years of Supervisory or Department Lead experience in managing employees, processes
* Lead audit and inspection experience with ISO and FDA.
* Strong computer skills and understanding of electronic quality management systems.
* Exceptionally strong team player with excellent interpersonal and communication skills, and
experience working with end-users in a mentoring capacity.
* Extremely detail oriented with strong organizational skills and high quality standards.
* Outstanding skills in grammar, punctuation, and spelling.
* Self-initiation drive, hands-on, motivated problem solver, ability to lead by example, and
enthusiastic, optimistic outlook are characteristics strongly sought in this position.
• Experience in other functional areas (R&D, QC, Operations) preferred.
• Experience with molecular diagnostic assays preferred.
Other Job Information
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