About Us
Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The Company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Cepheid's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the Company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market.
http://www.cepheid.com/
Cepheid@agents.icims.com
Job Summary:
This position supports Design Control and Quality System activities related to new product development - also supports improvement of systems, products, process and procedures. The ideal candidate will have a Quality Engineering and/or process scale-up background in a medical device or pharmaceutical company. Quality Engineering activities must be in concordance with FDA GMP, Quality System Regulations, current Good Manufacturing Practices and ISO-13485 standards.
Responsibilities:
Duties & Responsibilities:
• Support quality engineering activities related to design quality, safety and reliability
• Assist in establishing and revising specifications for raw materials, in-process and final product.
• Establish and analyze metrics to track component and final product quality and process efficiency; assess both newly-developed processes and changes to commercial products.
• Analyze processes for improvements and economy-of-scale efficiencies to improve cost-savings and product quality while managing technical and compliance risks
• Perform investigations for product nonconformance, perform root-cause analysis and make related recommendations for product and process improvements
• Participate on project teams; provide technical and design control input for developing products
• Determine required testing procedures to demonstrate compliance to design input requirements.
Required Knowledge, Skills, & Abilities:
Knowledge & Skills:
• BS in Engineering, Chemistry, Biology or related field
• Experience in the pharmaceutical or medical device industry required, with applicable knowledge cGMP, ISO, and QSR requirements
• Prefer at least 5 years experience in Quality Engineering, manufacturing scale-up or process engineering in a FDA-regulated environment
• Effective interpersonal skills, ability to teach and guide others, ability to successfully communicate with multiple departments
• Effective written and verbal communication skills, ability to write clear procedures
• Excellent problem solving and analytical skills
• Hands-on knowledge of statistics and design of experiments (DOE) preferred
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- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.