POSITION OVERVIEW

We are looking for a talented Quality Systems Specialist to join our team here at Canon Medical Informatics! In this role you will provide exceptional technical guidance and support throughout every aspect of the business to ensure alignment of global regulations and standards, and optimize continuous improvement of internal operations.

RESPONSIBILITIES

• Provide support for risk assessment, CAPAs, document control, supplier management, internal audits, risk assessments, health hazard assessments, post market surveillance activities.
• Facilitate a consistent environment worldwide where all information that defines our products and processes is clear, concise, and valid.
• Ensure the processes used for product definition, change, quality, compliance, and traceability are at the highest levels of effectiveness and efficiency.
• Monitor the strategic impacts of Canon Medical Informatics’ quality systems implementation, execution, and continual optimization.
• Continuously look for ways to improve and optimization the quality system processes and documentation.
• Analyze and report on quality system effectiveness.
• Assure all actions required to optimize the quality, manage the risk, and maintain the compliance of our products are planned and completed, and that the results drive quality and quality system actions.
• Facilitate the execution of one or more quality system processes (i.e. change management, CAPA, auditing, design controls, risk assessment, hazard assessments, post market surveillance, etc.)
• Serve as a Quality representative on product development and sustaining engineering project teams.
• Provide support for and participate as a subject matter expert in external regulatory audits.
• Develop and conducts Quality System training programs.
• Facilitate the implementation of electronic management systems (i.e. document control, CAPA, training, audits, etc.)
• Assist in preparation of product submissions to regulatory agencies.
• Interpret external regulations, agency guidelines, and internal policies to assure compliance.

REQUIRED EDUCATION AND SKILLS

Required:

• Bachelor’s Degree in Biology, Statistics, Science or Business-related field and/or 5+ years’ experience in medical devices and in multiple quality system elements and processes.
• Comprehensive knowledge of:
• ISO 13485 international standard for quality management systems.
• U.S. FDA medical device laws and regulations, Quality System Regulation (QSR) and MDSAP requirements.
• The MDR/CMDR and other international medical device regulations is required.
• Experience defining quality management system architecture and developing SOP’s, templates, and forms.

Preferred:

• Certification in Quality, Auditing, Six Sigma, or Configuration Management Experience with implementation of computer-based quality management systems and applicable regulations (21 CFR Part 11)
• Comprehensive knowledge of IEC 62304 Medical Device Software Lifecycle standard, EN 62366 Engineering Usability standard and risk management principles (ISO 14971)
• Strong working knowledge of software development, verification and validation processes.

JOB COMPETENCIES

• Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs.
• Global Perspective - Has a global view and is comfortable and effective working with global partners, understands global markets and international considerations.
• Listening Skills - Listens attentively to others, asks clarifying questions, actively listens, stays open to other viewpoints, manages distractions and interruptions.
• Quality Work - Is attentive to detail and accuracy, is committed to excellence, looks for improvements continuously, monitors quality levels, finds root cause of quality problems, owns/acts on quality problems.
• Research/Information Finding - Finds needed data through known sources; has good contacts or source knowledge; uses resourcefulness to tap as-yet-unknown sources; identifies, sorts and categorizes source materials to deliver most pertinent information.

COMPANY OVERVIEW

At Canon Medical Informatics (formerly Vital Images, Inc.), what we do matters. This is at the heart of every product we develop, every service we provide, and especially each member of our team. As part of Canon Medical Systems Corporation, we lead the industry with the latest health imaging informatics solutions. We improve the quality of patient care by developing innovative products that enable the exchange, analysis and storage of clinical information across health care enterprises and communities. Our products handle millions of medical images and health records a day across the world. Canon Medical Informatics experiences the best of both worlds with a dynamic and collaborative environment, casual culture, and agility of a mid-sized company, while having the support and resources of Canon Medical Systems Corporate, our parent company.

Our offices are based in Minnetonka, Minnesota; Waterloo, Ontario; Copenhagen, Denmark; The Netherlands; and Beijing, China. We value our team’s innovation, enthusiasm, and dedication to help improve the lives of patients. Do you want to be part of a passionate team that believes what we do matters? Then a career with Canon Medical Informatics might be right for you!

COMPANY VALUES

Unity, Courage, Tenacity, Teamwork, and Excellence

WHAT WE OFFER YOU

Canon Medical Informatics offers a dynamic workplace, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you’ll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn’t sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. In our office of 175, we have on onsite deli, workout facility and weekly massages. Our team loves what we do and has fun doing it together. We look forward to receiving an application from you.

Canon Medical Informatics is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.