Johnson & Johnson Careers

Quality Specialist, Documentation

Irwindale, California
Quality Systems

Job Description

Requisition ID: 5251180919

Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Quality Specialist, Documentation for Biosense Webster located in Irwindale, CA.  The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing.


Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.


The Quality Specialist, Documentation is position is responsible for planning, coordinating, executing an effective and efficient document change control process to ensure compliance with company and regulatory requirements.


Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Initiates and executes an effective and efficient change control process in accordance to internal and external requirements
  • Assists Documentation Supervisor with improvement and standardization of Document Change Control processes.
  • Maintains an effective change and version control of all documents.
  • Supports NPD pipeline projects
  • Investigates and resolve NCRs, Internal Audits, CAPAs related to Documentation Services 
  • Provides oversight/support of periodic document review process to drive timely completions.
  • Assists with reporting and analysis of Change Control metrics
  • Serves as PLM super user and train new associates or document owners in document management processes 
  • Follows all standard operating procedures
  • Performs other duties assigned as needed
  • 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



  • A Bachelors degree and at least 2 years of relevant experience in Quality Systems  or Document Management in a regulated industry is required.
  • Knowledge of GDP, and FDA and ISO standards are required.   
  • Experience providing support for internal audits and inspections by regulatory authorities is preferred.
  • Experience with CAPA, NCR and internal audit process is preferred
  • Prior exposure to various functions of corporate organization and cross-functional experience is preferred
  • Experience working with product development and/or manufacturing is preferred   
  • Excellent interpersonal and communication skills are required
  • Excellent time management and problem-solving skills, and the ability to work in fast paced environment and rapidly shift priorities are required
  • Must be detail oriented and accurate and able to quickly adapt and navigate various technology and computer software.
  • Ability to communicate with multiple levels of management is required
  • Proficiency in Microsoft Office Applications, Adobe Acrobat, and some knowledge of database application is required.
  • The position is located in Irwindale, CA and may require approximately 10% travel (domestic & international).

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