Medical Device Document Control Specialist

Company: Canon U.S.A., Inc.
Location: Cambridge
Posted on: May 3, 2021

Job Description:

Overview: Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Quality for the development of unique electromechanical and software based biomedical devices in collaboration with world leading medical institutions. We are seeking an experienced Medical Device Document Control Specialist (Specialist, Document Control) who can support our Document Control effort, support the maintenance of our Quality Management System and drive compliance. Responsibilities: - Responsible for supportingthe execution of document control activities to ensure compliance to applicable medical device Quality Management System (QMS) policies, procedures and executed forms (e.g. design, development, production, labeling and distribution records) and associated regulations or standards (e.g. US QSR, ISO 13485, etc) - The execution of control and traceability of QMS documents will be completed updating and maintenance of logs, databases and catalogues in compliance with applicable QMS and regulatory requirements (e.g. ISO 13485 and FDA) - This position will support conduction of the required periodic review/inspection assessments of QMS documentation (e.g. executed design, development, production and distribution forms and templates for compliance to CBMI QMS policies and procedures, ISO 13485, US 21CFR11, and US 21CFR820 requirements) - Prepares status reports, assigns and monitors document numbers and reviews documents for completeness - Assists in the compilation of regulatory filing documents by gathering information from Electronic Document Management System (EDMS) - Possesses specialized knowledge or skills in a particular functional area - A developing professional, working towards full proficiency in the job role - Receives general instruction from manager on expected work outcomes and exercises good judgment in day-to-day matters - Typically reports to a Manager or Senior Manager, but may report to a senior professional individual contributor when business needs dictate Qualifications: - 3 to 5 years working knowledge in Document Control or an administrative Quality role in the field of medical devices, in-vitro diagnostics, molecular diagnostics or related industry - A university-level Bachelors degree in a related field is an asset - Experience with MasterControl is a plus - Additional competencies or skills is working knowledge with eDMS programs, and a general understanding of the QMS requirements of Design Control, Production, Labeling and Distribution The company will not pursue or support visa sponsorship for this position. Company Overview: 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 2018 and is one of Fortune Magazine's World's Most Admired Companies in 2019. 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 pr@cusa.canon.com. Based on weekly patent counts issued by United States Patent and Trademark Office. All referenced product names, and other marks, are trademarks of their respective owners. Canon U.S.A., Inc. offers a competitive compensation package including medical, dental, vision, 401(k) Savings Plan, discretionary profit sharing, discretionary success sharing, educational assistance, recognition programs, vacation, and much more. A more comprehensive list of what we have to offer is available at https://www.usa.canon.com/internet/portal/us/home/about/careers/benefits-compensation/ We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans. If you are not reviewing this job posting on our Careers site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers. #CUSA Posting Tags: #PM19 #LI-AV1 #CUSA

Keywords: Canon U.S.A., Inc., Cambridge , Medical Device Document Control Specialist, Healthcare , Cambridge, Massachusetts