Manager, Microbiology & Sterility Assurance

Biosense Webster, Inc., part of the Johnson & Johnson

Family of companies, is currently recruiting for a Manager, Microbiology &

Sterility Assurance, to be located in Irwindale, 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 company’s CARTO® 3

System in 2009 revolutionized 3D mapping technology by increasing the accuracy,

speed, and efficiency of the cardiac ablation procedure. The Manager, Microbiology & Sterility Assurance will

have oversight and management over the Microbiology Lab, including New Product

Development (NPD) / R&D testing and assessment support, and environmental

monitoring functions as well as sterility assurance validation programs. Provides subject matter expert (SME) support

for R&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 &

RESPONSIBILITIES

Oversee and manage microbiological and

sterilization testing and assessments for R&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&D and QE NPD 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&D, Enterprise and other microbiological/sterilization

driven initiatives.

Provide SME support for J&J global affiliate

groups related to Quality Compliance, product registrations, and general

microbiology/sterilization inquiries.

Participates in R&D and QE NPD teams as

microbiology/sterilization SME.

Participates as BWI management representative in

projects involving Johnson & Johnson Sterility Assurance (JJSA) corporate

sterilization group.

Participates as BWI management representative in

pertinent JJSA leadership meetings and councils.

Oversee and manage product bioburden testing

program for Biosense Webster’s U.S. and Mexico facilities, as well as for

investigations and to support R&D, NPD projects.

Oversee and manage the environmental monitoring

program for clean rooms, water system and clean compressed air system.

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.

Review of test results generated by the internal

microbiology lab, and external laboratory services.

Generate and/or provide guidance and maintenance

of specifications and SOP’s 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 sterilizers.

Provide support in preparing the annual

Microbiology Department budget and oversee the ordering and purchasing of

laboratory supplies and equipment.

Generation of capital request for equipment as

needed or directed by the department manager.

Providing budget recommendations for the

department manager as requested.

Generating and providing corrective action

recommendations for all non-conformances related to the microbiology lab,

sterility assurance and environmental monitoring.

Provide recommendations, support and possibly

lead process validations that pertain to sterilization, environmental process

control, water system and clean compressed air.

Provide recommendations and support on equipment

or test method validations for equipment used within the microbiology lab or by

the microbiology team.

Function as a Team Member representing

Microbiology and Sterility Assurance on product transfers.

Lead Project Teams oriented toward improving the

efficiency, cycle time, and cost associated with sterilization and microbiology.

Establish metrics and measure/trend for

sterilization effectiveness and sterilization to final release cycle times.

Work closely with Facilities Engineering and

coordinate required testing after maintenance on the following validated

facility systems: Clean rooms, Purified Water, and Clean Compressed air.

Provide support for microbiology issues

related to Biosense Webster’s U.S. and Mexico facilities.

Other miscellaneous duties, including

oversight and management of final release inspection as needed to support the

business.

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.

Responsible for ensuring personal and Company compliance with all

Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed.

Qualifications

A Bachelor’s degree in a related field of study

and a minimum of 6 years’ experience as a Quality Professional in the Medical

Device industry is required. A Master's

degree is preferred.

Ability to use broad knowledge of regulatory,

technical, and business requirements to perform microbiology work is required

Ability to apply project management skills to

measure and improve performance in areas of responsibility is required

Ability to develop and implement Quality

standards is required

Knowledge of Quality and operations systems and

processes, including GMP and QSR requirements for medical devices is required

Demonstrated auditing and problem-solving skills

is required

Understanding of Six Sigma and Process

Excellence tools and methodologies is preferred

Ability to effectively train, mentor and

influence a diverse array of employees at all levels of the organization is required

This position will be located in Irwindale, CA

and may require up to 10% domestic and international travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity

Employer. All qualified applicants will receive consideration for employment

without regard to race, color, religion, sex, sexual orientation, gender

identity, age, national origin, or protected veteran status and will not be

discriminated against on the basis of disability.Primary LocationUnited States-California-Irwindale-OrganizationBiosense Webster Inc. (6010)Job FunctionQuality AssuranceRequisition ID4141190905