Sr. Document Management Specialist
Sr. Document Management Specialist
Be a part of the Quality team at our Healthcare Optics Research Laboratory bringing unique biomedical devices to the market in collaboration with world leading medical institutions. We are seeking an experienced Senior Document Control Specialist (Sr Specialist, Document Mgmt) who can manage the site’s Document Control activities.
– Manage the site’s electronic Document Control (EDM) System and Training Management System. Responsible for all day-to-day Document Control and Training Coordinator activities
– Review documents, Document Change Orders, and change packets to ensure compliance with procedures and good documentation practices
– Ensure that change orders are processed and documents released in a timely manner. Ensure that Document Change Order implementation plans are tracked and completed, including providing documentation to Contract Manufacturers for changes
– Serve as subject matter expert on the Document Change Order and approval processes. Train and mentor personnel on these processes and the use of the EDM system
– May assist personnel in writing Document Change Orders, organization and formatting of documents, and similar activities
– May conduct the required periodic review assessments of Quality System documents
– Manage paper and electronic records from Quality System processes such as the CAPA, New Product Development, Supplier Management and Nonconforming Material processes. Review records for GDP compliance. Perform tracking for these processes, as requested, to ensure completion of tasks and documentation. May perform Quality System support for these processes
– Support internal Quality Audits as well as external Quality Audits by regulatory and other accrediting agencies by providing documentation and backroom support
– Purchase and maintain standards library (including subscription services), guidance documents, and regulatory documents
– Track key Quality metrics, as requested for Management Review
– Lead or participates in continuous improvement projects and corrective actions, as needed
– Participate in the compilation and review of 510(k) submissions, and other regulatory filing documentation
– Minimum of a Bachelor’s Degree
– Minimum of 5 years of working experience in a Document Control, Quality Assurance or Compliance role, preferably in a document control or management function in an FDA regulated industry (preferably Medical Devices)
– Working Knowledge of 21 CFR Parts 11 and 820, including ISO 13485 QMS
– Experience with an Electronic Document Management (EDM) system, strongly preferred
– Experience in participating in compliance audits or inspections preferred
– Proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
– Must possess strong organization skills and strong oral and written communication skills
– Strong ability to coach and mentor others–including an ability to effectively train personnel within a classroom or workshop setting
– Must be a team player
About our Company – Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2017† and is one of Fortune Magazine’s World’s Most Admired Companies in 2018. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company’s RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact firstname.lastname@example.org.
† Based on weekly patent counts issued by United States Patent and Trademark Office. .
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