SENIOR CHANGE CONTROL ANALYST-0264141118
Description
Biosense Webster, a Member of the Johnson and Johnson Family of Companies, is recruiting for a Senior Change Control Analyst in Irwindale, CA.
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.
The Senior Change Control Analyst will oversee, and provide guidance over the change control group, including leading the analysts/ specialists daily activities, supporting NPD projects, Periodic review, and standards monitoring and assessments.
Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position has the following responsibilities and duties:
Support and maintain robust change control process. Train and lead Change control analysts / specialist according to our procedures and processes. Confers with documents originators or engineering liaison personnel to resolve discrepancies and compiles required changes to documents.
Guide and training ECO authors with creating and enters engineering change control data into cPDM. Review, approve and release ECOs, P/TRs and all sub components in the engineering change order. Support and maintain the process to review and manage external standards
Support and maintain the process to review and maintain the periodic review process. Support NPD pipeline projects.
Prioritize approval and release of ECO, P/TRs based on business priorities .Oversee the creation and release of Engineering Change Orders and labeling; and support in PLM projects validation, and maintenance of the training process. Make recommendations to supervisor to improve department operating efficiency. This position ensures that all standard operating procedures are followed.
Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. This role is also responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
The Senior Change Control Analyst is also responsible for other duties as needed/assigned.
Qualifications
A Bachelor Degree in any major or enrolled in university pursuing a Bachelor degree. Or 8 years’ experience in Change control process in lieu of Bachelor degree, is required. A minimum of 2 years of combined work experience in Change Control, data management or equivalent technical capacity field is required. Experience with a variety of software programs, specifically JD Edwards, PLM system . Project management experience is preferred. Familiarity with SDLC concepts (Software Development Lifecycle) is preferred. Experience in the medical device industry preferred.
Knowledge of software system dependencies and data management is required. Knowledge in Microsoft products (i.e. Excel, Powerpoint, Word, etc), is required. Excellent analytical skills are also required. Excellent interpersonal and communications skills are required. The ability to produce an extremely detail oriented and accurate work product is required.. The ability to work in fast paced environment and rapidly shift priorities is required. The proven ability to quickly adapt and navigate various technology and computer software is desired. The ability to communicate with multiple levels of management is required.
This position is located in Irwindale, CA and requires up to 5% travel.
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Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Job Function: Quality Systems
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