Medical Device Quality System Manager
Company: Canon USA
Location: Cambridge
Posted on: January 15, 2021
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Job Description:
Location: US-MA-CambridgeRequisition ID: 24285Category: Medical
DevicePosition Type: Full-TimeOverview
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.
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 and 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 PI128716701
Keywords: Canon USA, Cambridge , Medical Device Quality System Manager, Healthcare , Cambridge, Massachusetts
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