CSS Document and Change Management Supervisor

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Job Description

Biosense Webster, Inc. a member of Johnson & Johnson Family of companies is recruiting for a CSS Document and Change Management Supervisor.

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 CSS Document and Change Management Supervisor will have responsibilities for managing the Document and Change Management Process across CSS and provides direct oversight for the BWI and Acclarent change control groups including leading document control daily activities, supporting NPD projects, ownership of the periodic review process, monitoring Change Control metrics and supporting PLM upgrades and deployments to the business.

Key Responsibilities:
• Manage Periodic Review Process and Procedures for CSS sites in applicable Product Lifecycle Management (PLM) System. Partner with Medical Device Document and Change Management leaders to identify continued improvements and enhancements for the Document and Change Management process, Periodic Review Process and corresponding PLM Systems.
• Drive continuous improvement of document management processes within MD, actively seeking methods to reduce cycle times.
• Execute Franchise specific and Johnson & Johnson Medical Device strategies to standardize and optimize processes where appropriate.
• Lead and train team to required procedures and processes.
• Coach and develop team based on yearly development plans and goals and objectives.
• Prioritize approval and release of Change Control documents based on business priorities.
• Lead or support special assignments or projects, as needed, such as acquisitions/divestures, deployment of new applications or processes, continuous improvement efforts, or business projects such as new product development.
• Address issues related to document management for internal and external (FDA, BSI, etc.) audits as needed.
• Investigate and resolve Nonconformances, Internal Audits, CAPAs related to Documentation Services
• Assist in the creation and development of metrics to evaluate the effectiveness and efficiency of Document Change Control Processes.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring direct reports 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.

• Bachelor’s degree in Science/Engineering plus 5 years of experience or a Bachelor’s degree plus 7 years of experience
• Minimum of 4 years experience within medical device industry required
• Minimum of 4 years experience in document management or using an electronic document management system is required.
• Minimum of 2 years management experience required
• Ability to multitask, including ability to understand customer requirements, retrieve information, and provide responses satisfactorily and with immediacy is required.
• Ability to learn and manipulate complex computer system applications is required.
• Knowledge of GDP, 21 CFR Part 820 (QSR) and ISO 13485 (QMS) requirements are required.
• Experience providing support for internal audits and inspections by regulatory authorities is required.
• Experience with CAPA, Nonconformances and internal audit processes is required.
• Experience in working with product development and/or manufacturing is required.
• Experience in developing and motivating direct employees is preferred.
• Excellent interpersonal skills
• Excellent communications skills
• Excellent time management and problem solving kills
• Detail oriented and accurate
• Ability to work in fast paced environment and rapidly shift priorities
• Ability to quickly adapt and navigate various technology and computer software.
• Ability to communicate with multiple levels of management
• Proficient in Microsoft Office Applications, Adobe Acrobat, and some knowledge of database application
• 10% domestic or international travel may be required

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 Location
United States-California-Irwindale-
Biosense Webster Inc. (6010)
Job Function
Quality Systems
Requisition ID