Senior Analyst, Quality Systems Job in Irwindale, California US
Biosense Webster, Inc (BWI), a member of Johnson Johnson's Family of Companies, is recruiting for a Senior Analyst Quality Systems, to be located in Irwindale, California.
Biosense Webster, Inc, is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.
As part of the Product Life Management group, the Senior Analyst, Quality Systems is responsible for the quality systems software management, systems analysis, system and business risk assessment. This individual will interface with multiple business units within BWI worldwide and partner with IT to support the business's strategic objectives, prioritize initiatives and identify opportunities for technology to add business value in conjunction with business leaders. This individual will be responsible for managing, updating and analyzing quality systems software. The Senior Analyst, Quality Systems will create and oversee proactive projects that typically require extensive systems integration, large teams and multiple technical platforms, with global implications. This individual will perform risk assessment and develop contingency plans and recommendations should unanticipated situations arise. This individual is responsible for supporting documentation services by updating a minimum amount of engineering drawings using CAD software. The Senior Analyst, Quality Systems will support administrative changes, perform basic product configuration and develop engineering change notice packages. This individual will generate and release product labeling changes which include artwork, labels, IFUs, and manuals. In addition, this individual will confer with document originators or engineering liaison personnel to resolve discrepancies and compile required changes to documents. Finally, this individual will also assist customers in coordinating engineering change notices.
Qualifications
A minimum of a Bachelors degree is required. A focused degree in Computer Science, Engineering and/or Certificate is highly preferred. A minimum of 3 years of combined work experience in software, data management on in a Medical Device or similarly regulated industry is required. A minimum of 2 years of general business experience with strong knowledge of business processes is required. Experience with JD Edwards, PLM Systems (cPDM, Matrix One,enLabel, Compliance Wire) and/or Oracle systems (Siebel) is preferred. Experience managing projects is required. Knowledge of SDLC concepts (Software Development Lifecycle) is preferred. Experience in the medical device industry is preferred. Experience with programming is a plus.
Strong attention to detail and accuracy is required. Strong analytical skills are preferred. Excellent written and verbal communication skills are required. The ability to quickly adapt and navigate various technology and computer software is required. The ability to work in a fast paced environment with rapidly shifting priorities is also required.
This position will require up to 10% travel and will be based in Irwindale, CA.
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