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Canon USA & Affiliates Medical Device Quality System Manager in Cambridge, Massachusetts

Overview

Canon USA’s Healthcare Optics Research Lab is collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. We are developing biomedical optical imaging and medical robotics technologies. Drive Quality excellence at our Healthcare Optics Research Laboratory for commercialization of our biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Medical Device Quality System Manager (Manager, Quality System (HORL)) professional who will drive continuous improvement of HORL’s Quality Management System while managing the document control function and eQMS processes.

Responsibilities

  • Drive continuous improvement of the Quality Management System, including proactive process audits, failure evaluations, root cause identification, and implementation of corrective actions

  • Manage the Document Control function and other eQMS processes as developed

  • Collaborate with contract vendors to integrate external processes under the HORL QMS as necessary

  • Prepare and update Quality documents and SOPs. Review and approve interdepartmental records, documents, and SOPs to ensure conformance with regulations and guidelines

  • Develop, execute, and document IQ/OQ/PQ software validation protocols for related QMS tools

  • Implement and maintain a program to report on RoHS, REACH, CalProp65, Conflict Minerals, and other controlled materials

  • Develop KPI’s and regular reporting methods on the same

  • Regular upkeep, reporting, and maintenance of Quality System data across various tools and databases

  • Support Management review meetings

  • Engage with cross-functional teams to facilitate horizontal process improvements

Qualifications

  • 10+ years medical device Quality experience, including demonstrated experience in FDA/ISO eQMS development and management

  • Demonstrated experience managing document control under a medical device QMS

  • ASQ certification as CMQ/OE is a plus

  • B.S. or higher degree in a technical discipline

  • Experience with MasterControl is a significant plus

  • Strong working knowledge of FDA, ISO 13485 and MDSAP requirements

  • Skills: Proficient in Microsoft Office.

  • Must possess strong oral and written communication skills

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 visitingand follow us on Twitter @CanonUSA. For media inquiries, please contact.

† 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.

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, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at.

#CUSA

Posting Tags

#PM19 #LI-AV1 #CUSA

Location US-MA-Cambridge

Company Canon U.S.A., Inc.

Requisition ID 24285

Category Medical Device

Position Type Full-Time

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