Senior Quality Systems Specialist

Location US-MA-Cambridge
Job ID
7456
Experience (Years)
5
Category
Medical Device

Company Overview

The Canon Healthcare Optics Research Laboratory is a division of Canon U.S.A., Inc.
 
Canon Healthcare Optics Research Lab (HORL) is a young organization that is gaining momentum. We’re partnering with world class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products.
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 (excluding Mexico) markets. With approximately $31 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2015† and is one of Fortune Magazine's World's Most Admired Companies in 2016. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. 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 is proud to be an equal opportunity employer. Minority/Female/Individuals with Disabilities/Protected Veterans. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identification, national origin, disability, genetic information or protected veteran status, or any other characteristic protected by law. To read more about employment discrimination protections under federal law, please visit this site: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

Position Overview

Be a part of the Quality team at our Healthcare Optics Research Laboratory and see your work have a strong impact on building the Quality infrastructure and moving innovative Medical Devices to market.  Work with a diverse group of people in a growing organization.  We are seeking an experienced Senior Quality System Specialist who can drive compliance in our Quality System processes.
 
#LI-CM1

Responsibilities

- Manages Quality System processes including Document Control, Supplier Management, and CAPA processes. 
- Assists in the development of Quality System processes and ensures that they are properly implemented.
- Prepares and completes Document Change Orders including training as requested. 
- Plans, coordinates, and presents Quality System training and new employee quality system orientation training. 
- Supports and coordinates internal and external regulatory agency audit activities as assigned.
- Monitors and tracks the implementation of corrective action/preventive action (CAPA) and reports progress to management on a routine basis. 
- Provides mentorship on CAPA activities such as root cause analysis, corrective action plans and effectiveness verifications. 
- Applies statistical methods in support of tracking/trending of data and in problem solving related to the development and application of solutions to CAPAs and other quality system activities.
- Leads supplier management efforts, including supplier approval, supplier audits and developing quality agreements.
- Plans and executes internal audits against applicable quality system standards, regulations and internal requirements.
- Manages the implementation of electronic Document Control and Quality Management System processes.
- Prepares and presents quality metrics at Management Review Meetings.

Qualifications

- Education: BS or higher degree 
- Experience: 5 years minimum quality experience in Medical Devices, including experience with CAPAs. Experience in supplier management is a plus. 
- In-depth understanding of 21 CFR part 820 and ISO 13485.
- Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus.
- Skills: Proficient in Microsoft Office. Experience in Minitab, JMP or similar statistical package.
- Must be a team player and possess strong oral and written communication skills.
- Applicants are encouraged to provide writing samples that demonstrate their capabilities in writing quality documentation and quality system procedures.
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.

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