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Medical Device Quality System Manager

Medical Device Quality System Manager

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 experience 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. 

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