Biosense Webster, a member of the The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Quality Specialist, Documentation to be located in Irwindale, CA.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, Codman Neurovascular and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
SUMMARY OF THE JOB
This position is responsible for planning, coordinating, executing an effective and efficient document change control process to ensure compliance with company and regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Initiate and execute an effective and efficient change control process in accordance to internal and external requirements
• Assist Documentation Supervisor with improvement and standardization of Document Change Control processes.
• Maintain an effective change and version control of all documents.
• Support NDP pipeline projects
• Investigate and resolve NCRs, Internal Audits, CAPAs related to Documentation Services
• Provide oversight/support of periodic document review process to drive timely completions.
• Assist with reporting and analysis of Change Control metrics
• Serve 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
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
• A combination of one of the following is required: o Bachelor’s degree in Physical Science/Engineering plus 2 years of relevant experience or any Bachelor’s degree plus 3 years of relevant experience is required.
• Minimum of 2 years of direct experience in Quality Systems within medical device industry required or a minimum of 2 years’ experience in document management which includes use of an electronic document management system is required.
• Knowledge of GDP, 21 CFR Part 820 (QSR) and ISO 134085 (QMS) requirements required.
• Experience providing support for internal audits and inspections by regulatory authorities is a plus.
• Experience in CAPA, NCR and internal audit process is a plus
• Prior exposure to various functions of corporate organization is a plus
• Experience in working with product development and/or manufacturing is preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
• 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
This position is located in Irwindale, CA and may require some travel.