Biosense Webster, Inc., part of the Johnson and Johnson Family of companies, is currently recruiting for a Manager, Microbiology and Sterility Assurance, to be located in Irwindale, CA or Irvine, CA.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart:related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real:time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the companys CARTO(R) 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
The Manager, Microbiology and Sterility Assurance will have oversight and management over the Microbiology Lab, including New Product Development (NPD) / R and D testing and assessment support, and environmental monitoring functions as well as sterility assurance validation programs. Provides subject matter expert (SME) support for R and D, QE:New Product Development (NPD), Regulatory Affairs (RA), Supplier Quality Engineering (QE) and Compliance, and other groups in relation to microbiology, sterilization and biocompatibility throughout lifecycle of product.
DUTIES and RESPONSIBILITIES
Oversee and manage microbiological and sterilization testing and assessments for R and D and QE NPD materials, components, sub:assembly and finished product.
Supports development and implementation of microbiology/sterilization practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Lead or participate in efforts related to quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
Oversee and manage biocompatibility testing and assessments for R and D,QE NPD, Manufacturing materials, components, sub:assembly and finished product.
Generates microbiological, sterilization and biocompatibility reports to support RA department regulatory agency submissions and provides SME support for responses to inquiries that may stem from such submissions.
Participate and provide support as BWI representative in MD and D, Enterprise and other microbiological/sterilization driven projects and initiatives.
Provide SME support for J and J global affiliate groups related to Quality Compliance, product registrations, and general microbiology/sterilization inquiries.
Participates as BWI management representative in leadership meetings and projects involving Johnson and Johnson Microbiological Quality and Sterility Assurance (JJMQSA) corporate group.
Oversee and manage product bioburden testing program for Biosense Websters U.S. and Mexico facilities, as well as for investigations and to support R and D, NPD projects.
Training and mentoring of Microbiology Scientists, Technicians and other Quality personnel conducting microbiology work.
Management of the microbiology lab Scientists and technician(s) and any other personnel working within the microbiology lab or performing microbiology work.
Generate and/or provide guidance and maintenance of specifications and SOPs that pertain to microbiological testing of product, microbiological testing of clean rooms, water and clean compressed air.
Provides SME support for periodic on:site audits of contract sterilizers and analytical laboratories as availability permits and per approval from department manager.
Oversee and manage annual validations of contract ethylene oxide sterilizers.
Provide support in preparing the annual Microbiology Department budget and oversee the ordering and purchasing of laboratory supplies and equipment.
Lead Project Teams oriented t