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WHAT
IN
Manager Global Complaints Process - Irwindale CA
Job
Johnson & Johnson
US
-
Irwindale,
California
Job Code - 11970
Position - See job description
Job First Active on: Sunday, November 01, 2009
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JOB DESCRIPTION: Manager, Global Complaints Process - Irwindale, CA
Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Complaints Process, located 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.
This position will serve as the management representative for the Global Complaint Management and Investigation Process at Biosense Webster. The Manager, Global Complaints Process is responsible for management of the Global Complaint Process. Responsible for overall complaint investigation process and management of the product analysis lab. Responsible for timely complaint closures and linkages of investigations to individual complaint records. Monitor linkage metrics and subsequent complaint closure metric. Responsible for effective management of MDR/MDV and all other applicable global adverse event reporting to meet regulatory requirements and company goals. Will manage continuous improvement of the global Complaint Management process using Best Practice, World Class, PE approaches and ensure continuous compliance with FDA and all other applicable regulations and ISO standards and reduce regulatory exposure through increased efficacy in management of product complaints by improvement in multiple complaint process metrics. Develop and optimize systems and processes that are aligned with the overall business and the Quality Vision. Ensures that these systems and processes provide a measurable impact to quality, cost and customer value. Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV) as well as all other applicable global reporting requirements and will maintain up-to-date knowledge of FDA & EU regulations and applicable worldwide standards and requirements.
The Manager, Global Complaints Process will also manage all customer interface points to the complaint handling process and ensure timely and effective communications with customers regarding complaints and complaint investigations. Ensures customer satisfaction by optimizing customer communication from first interface with the call center until final follow-up. Will be responsible for preparation, on-site management and follow-up for compliance standards and corporate audits in the Quality department as it relates to the Global Complaint Process as well as managing and participating in pre-assessment and post-certification audit activities. Maintain and develop effective relationships with all stakeholders, including business unit QA/RA heads. Function as subject matter expect for CSI Siebel complaint management software system. Ensure a technical liaison between Compliance, R&D and Operations in terms of product complaints, with respect to compliance concerns. Assure that post-market product experience is fed back into both sustaining engineering and new product development. Advise staff to help meet established schedules or resolve technical or operational problems. Estimate and administer performance standards, follow all company safety policies and other safety precautions within the work area, set standards for safe behavior and recognize and reward safe behavior in others. Responsible for ensuring management reviews of the Global Complaint Process are conducted.
REQUIREMENTS - QUALIFICATIONS: Manager, Global Complaints Process - Irwindale, CA
A minimum of a Bachelor's degree in Engineering, Physical Science, Biological Science, or a related discipline is required. An advanced degree is an asset. A minimum of 5+ years experience as a Quality Professional in the Medical Device or Pharmaceutical industry is required. A minimum of 3+ years previous supervisory experience is required. Complaint Management experience strongly preferred. Knowledge of QSR and MDR with respect to complaint management application is required. GMP knowledge required. MDD and Vigilance Reporting knowledge in EU and Outside US is preferred. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
Johnson & Johnson
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