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Johnson & Johnson
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  • Job Title:
    PROGRAM MANAGER - WW QUALITY COMPLIANCE Job
  • line
  • Company:
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  • Location:
    Irwindale, CA
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  • Job Status/Type:
    Full Time
    Employee
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  • Job Category:
    Quality Assurance/Safety
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  • Reference code:
    JW-4293140604
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Position Description

PROGRAM MANAGER - WW QUALITY COMPLIANCE Job

Johnson & Johnson companies are equal opportunity employers.

PROGRAM MANAGER - WW QUALITY COMPLIANCE-4293140604

Description

Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Program Manager, WW Quality Compliance, 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.

The Program Manager, WW Quality Compliance serves as the Quality Compliance technical lead for providing guidance and Regulatory interpretation to support the business in driving and managing overall quality and compliance at Biosense Webster. This individual is responsible for implementation of the Compliance strategy including leading and managing activities associated with Management Reviews, internal audits, external audits, Quality Review Board Meetings, and coordination of recall activities with FDA and BWI affiliates. Also responsible for global implementation of ISO requirements, development and implementation of tactical plans to meet Company and Corporate objectives, and supporting the development and implementation of policies to ensure compliance with applicable US Federal and local compliance regulations. Applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.

The Program Manager, WW Quality Compliance is 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) as well as all other applicable global regulatory requirements. Schedules, coordinates and prepares for Management Review by gathering all required information from all sites/required groups, performing dry runs, managing the process, preparing minutes, following up on action items and maintaining records. Reviews company audit readiness strategy and oversees organizational preparedness for FDA, Notified Body and other Regulatory Body inspections. Coordinates and manages external regulatory agency and notified body assessments and inspections (example: FDA, ISO). Reviews and participates in issues and/or decisions related to assessments including pre-assessment and post-certification audit activities. Provides organizational coordination during Agency /3rd Party Audits and oversees the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.

This individual functions as the technical liaison between Compliance, R&D and Operations in terms of product objectives, with respect to Compliance concerns. Functions as technical compliance liaison and lead to all BWI sites. Provides guidance on Regulatory interpretation to support the business in driving and managing overall and consistent company quality and compliance. Manages the Global Internal Audit Program, monitors execution, and ensures timely completion of observation response and action items. Facilitates and coordinates follows-up for escalation meetings and maintains related files. Manages field corrective actions, any associated regulatory actions and follow-ups; assists in product problem resolution as part of follow-up and CAPA. Maintains up-to-date knowledge of FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.

Implements/modifies quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required. Tracks effectiveness and takes corrective action on Management Responsibilities and Audit systems. Ensures compliance gaps are identified and escalated as required on all quality sub systems through effective use of Management Controls systems. Advises staff to help meet established schedules or resolve technical/operations problems. Maintains company Compliance Scorecard and related documentation, and provides updates to Johnson & Johnson Corporate Quality regarding compliance status and performance as it relates to compliance activities. Responsible for completion and submission of the Food and Drug Administration (FDA) and State of California establishment registrations and keeping related matters current. Responsible for communicating business related issues or opportunities to next management level. Investigates and develops solutions to procedure and process related issues. Leads project teams to improve processes within Biosense Webster at either a local or global level. Develops in-depth understanding of EP procedures and Biosense Webster devices.

Responsible for following 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 including Health, Safety and Environmental compliance. Follows all company safety policies and other safety precautions within the work area. Sets standards for safe behavior. Recognizes and rewards safe behavior in others. Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Qualifications


A Bachelor’s degree and a minimum of 5 years of related Quality Compliance experience is required. A degree is a scientific or engineering disciple is preferred. A Master’s degree is preferred. Process Excellence Certification is a plus. Supervisory or team leader experience is required. Quality System experience in the medical device industry is required. Experience relating to “Subpart B – Quality System Requirements” (820.20 Management responsibility, 820.22 Quality Audit and 820.25 Personnel) and ISO 13485 is highly desirable.

Thorough knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices. (ISO13485, FDA’s QSRs, EU’s MDD, Canadian Regulations) is required. Proficiency in the Microsoft Office suite of products is required. American Society for Quality certification is preferred.

Up to approximately 15% international and domestic travel may be required. This position will be located in Irwindale, CA.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W:LI NA

Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Job Function: Compliance

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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