Vital, a Toshiba Medical Systems Group
Company, is a market leader in advanced visualization software
solutions for physicians and healthcare specialists. The company's
sophisticated technology gives radiologists, cardiologists,
oncologists and other medical specialist’s productivity and
communications tools that can be accessed throughout the enterprise
and via the Web at anytime and anywhere for patient care and
treatment planning. Vitrea® software has been installed at more
than 5,000 hospitals in over 80 countries. Established in 1988 and
headquartered in Minneapolis, Vital Images also has offices in Europe
and Asia. For more information, visit www.vitalimages.com.
BASIC PURPOSE AND OBJECTIVES:
Maintains the Vital
documentation system. Prepares and maintains controlled documents,
processes and documentation affecting quality systems, product
quality and regulatory status in compliance with worldwide medical
device laws and regulations and with the corporate quality policy to
ensure products are designed and manufactured to predetermined
specifications. Works directly with operating entities to ensure
process compliance is maintained. Assists in other quality systems
OVERALL OUTPUTS, DUTIES, AND
• Coordinates the timely review and
release of controlled documentation; e.g. – e.g. - design
documents, QSP’s, SOP’s, forms, templates, maintaining
record archives, Design History files, Device Master records, Device
History Records, Technical Files, etc.
documentation content and process compliance with regulations,
standards, and internal business requirements.
Coordinates periodic document review activities to ensure document
• Assists with the execution of other quality
system processes such as CAPA, internal audits, design controls,
document control, etc.
• Ensures documentation content and
processes are compliant with regulations, standards, and internal
• Assists with Quality Management
System internal auditing activities to ensure compliance with
internal processes and regulatory requirements.
Participates in continual optimization of quality system processes
• Assists in gathering data to analyze
and report on quality system effectiveness.
support for regulatory audits; e.g. – supplier record
retrieval, audit preparation and coordination, training records, etc.
• Assists in the implementation of electronic management
systems; e.g. – document control, CAPA, training, audits, etc.
• Assists in preparation of product submissions to
• Other duties as assigned.
EDUCATION AND EXPERIENCE REQUIREMENTS:
• At least 3
years experience in one or more quality system elements and processes
• Bachelors Degree in Biology, Statistics,
Science or Business preferred. Minimum requirement is a 2-year degree
and significant applicable experience. Four year degree is preferred.
• Must have working knowledge of U.S. FDA medical device
laws and regulations and Quality System Regulation (QSR).
• Must have working knowledge of ISO 13485 or ISO 9001
international standards for quality management systems.
Working knowledge of the MDD/CMDR and other international medical
device regulations highly preferred.
• Experience with
product development companies is required. Experience with software
and/or medical device manufacturers is highly preferred.
Certification in Quality, Supplier Management, Auditing, or
Configuration Mgt. highly desirable.
• Working knowledge
of risk management principles (ISO 14971) highly desirable.
• Experience with implementation of computer-based quality
management systems and applicable regulations (21 CFR Part 11) highly
• Experience developing SOP’s, templates,
and forms highly desirable.
SKILLS AND OTHER
• Proficiency with basic quality tools and
• Proficiency with MS Office applications and
• Ability to work closely with others
in high demand situations.
• Demonstrated excellent
written and verbal communication skills.
attention to details and accuracy.
Must be able to lift up to 25 lbs. No unusual physical
hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. Hours can
vary and expand as dictated by project demands.
We are an Equal Opportunity/Affirmative Action Employer