Senior Document Control Specialist

Robotics & Digital Solutions, part of the Johnson & Johnson Family of companies, is recruiting for a Senior Document Control Specialist located in Redwood City/Santa Clara, CA. Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our dedication to help address the world''s most pressing health care issues and improve and save more lives. Through Ethicon''s surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit The Sr. Specialist will play an important role in implementing the document and change control processes for changes to Documents and Records in a Agile PLM system. This role is responsible for providing internal customers with mentorship in following document and change control procedures. Key Responsibilities: Review changes in a timely manner for compliance with procedures. Select and/or verify required approvers of changes per procedures. Collaborate and provide mentorship to change owners, approvers, and business partners as needed. Collect and report metrics pertaining to change control activities. Communicate the status of changes. Lead small, prioritized projects that help support departmental objectives, including projects that require collaboration with other departments or facilities. Support and recommend change control process improvements including initiating procedural revisions. Support both internal and external audits, as well as quality events (CAPA, NC, Audit findings), relating to document/change control processes. Ensure all activities adhere to the documented quality system and current regulatory requirements. Qualifications Education: Minimum of a Bachelor''s, equivalent University Degree required Experience and Skills: Required: Minimum 6 years of relevant work experience Ability to collaborate in an open office environment and remotely with virtual teams while paying attention to detail Ability to coordinate, prioritize, and balance multiple projects and tasks simultaneously Strong written and verbal communication skills Experience with Product Lifecycle Management (PLM) systems, such as Agile PLM, ADAPTIV (Enovia platform), Windchill, and/or equivalent PLM systems Proficient in Microsoft Suite (Outlook, Word, Excel, and PowerPoint) Demonstrated knowledge of electronic change control processes supporting a regulated industry An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, and design control. Medical Device, Pharmaceutical, and/or Biotech experience Preferred: A solid understanding of Agile PLM strongly preferred Experience with MRP/ERP systems such as SAP Experience in analyzing and writing procedures Other: This position is located in Redwood City/Santa Clara, CA, and may require up to 10% domestic travel. At Johnson & Johnson, we''re on a mission to change the trajectory of health for humanity. That starts by creating the world''s healthiest workforce. Through powerful programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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-Redwood City-150 Shoreline Dr Other Locations United States-California-Santa Clara Organization Auris Health, Inc. (6267) Job Function Quality Requisition ID 2206067528W

Created: 2025-10-04