Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for Analyst 1, Quality System Document for Cerenovus located in Fremont, CA. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
You, the Analyst 1 Quality System Document in Quality System will:
Responsible for administering, maintaining, and monitoring the company's document control activities in accordance with FDA/QSR, ISO 13485 requirements and other international regulations
Responsible for implementing the processes and procedures as outlined in the document management system.
Examines documentation regularly for consistencies, gaps or errors. Works with relevant personnel to ensure accuracy of any revisions. Ensures revisions to master documents reflect approved changes, as directed.
Processes change orders for routine incoming documents including validation and verification protocols and reports.
Assists in implementing & execution in document control systems and quality records procedures.
Identify potential compliance issues, gaps, and negative trends to investigate, recommend and/or verify implementation of appropriate corrective/preventive actions.
Responsible for communicating business related issues or opportunities to next management level.
Collect and analyze data, and report metrics as established in processes and procedures.
Responsible for the record keeping and training documentation, including the computerized employee training and tracking system.
Participate in on-site inspections by internal personnel or external/ third party regulatory agencies
Participates in quality system improvement initiatives.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Minimum 4 - 8 years’ experience and a bachelor’s degree, or equivalent is preferred in the medical device industry with demonstrated quality system knowledge including 21 CFR Part 820 (QSR) & ISO 13485
Experience in the Medical Device industry or medical field
Knowledge of specific business practices and software and software applications
Ability to work cooperatively with coworkers and the public
Ability to perform duties in accordance with policies and procedures
Experience in a related field, preferably experience working within a quality management system for a medical device manufacturer, ISO experience is an asset
Document review and procedural writing experience is preferred
Competent in writing and formatting of procedures and documents
Proficient in computer applications such as, Microsoft Word, Excel, Access, Microsoft Share Point and Outlook
Experience with Document Management tools such as Adaptiv a plus.
High attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects simultaneously.
Strong communication and organizational skills.
Ability to work autonomously or in a team environment.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Depuy Orthopaedics. Inc. (6029)