Employment Opportunities - Data Innovations North America

Current Openings:

 

 
Quality and Regulatory Associate

Data Innovations North America, the world’s largest and most successful clinical and blood laboratory Middleware Company, is currently seeking a Quality and Regulatory Associate. The Quality and Regulatory Administrator supports all the administrative efforts of the daily operations of the Quality and Regulatory Department. This person’s primary responsibilities are to provide assistance to the administration, coordination, evaluation and compliance of the Quality and Regulatory department.  The Quality and Regulatory Administrator is expected to work independently, needing little direct supervision.

Essential Functions and Responsibilities:

  • Assist with developing and maintain procedures to ensure regulatory compliance
  • Assist with regulatory filings, ensure status are maintained and documentation is complete, including but limited to recalls, registrations, 510(k) submissions
  • Accurately complete documentation surrounding Driver Hazard Analysis and Patch Releases
  • Attend and provide input in Design Review meetings
  • Review and approve release documentation and off-the-shelf testing documentation
  • Maintain the Critical Alerts ListServ
  • Ensure established quality and regulatory procedures are followed
  • Maintain incidents in the quality and regulatory queue
  • Assist with maintaining Quality and Regulatory metrics
  • Update and accurately maintain departmental spreadsheets and reports
  • Perform activities related to company training, including but not limited to assisting department managers with maintaining training trackers and ensure compliance with regulatory training requirements
  • Accurately maintain the scheduling related to Quality and Regulatory training classes
  • Perform other related duties as assigned

Requirements

Knowledge, Skills, and Abilities:

  • Ability to understand the field’s concepts, practices and procedures
  • Proficient with Microsoft Office (Outlook, Word and Excel)
  • Ability to write clear, concise documents on a deadline
  • Ability to communicate clearly and professionally in verbal and written formats
  • Strong ability to organize, manage workload, set realistic deadlines and manage multiple priorities without direct supervision
  • Possess a strong attention to detail
  • Ability to follow DI’s policies and procedures
  • Meet travel requirements of the position

Education and/or Experience

Associate’s degree with at least 2 years of related working experience– preferably in a regulatory environment OR a combination of education and related working experience form which comparable knowledge and skills can be acquired.

Physical Requirements/Working Conditions:
While performing duties of this job, the employee is predominately functioning in a sedentary light office position with high frequency of telephone communication, keyboarding, and computer.

Preferred skills and experience:

In addition to the above requirements, the ideal employee/candidate will have experience with the following:

  • Experience and familiarity of quality system requirements
  • Experience with Microsoft SharePoint and CRM systems
  • Understanding of HIPAA
  • Working experience in a hospital or regulated industry

Supervision Level

This person reports directly to the Quality and Regulatory Manager.


 
Documentation Manager

Data Innovations North America, the world’s largest and most successful clinical and blood laboratory Middleware Company, is currently seeking a Documentation Manager. The Data Innovations Documentation Manager is responsible for managing all tasks associated with the documentation functions within the Company.  This person’s primary responsibilities are to ensure adequate creation, and maintenance of both internal documentation and user-focused documentation meet company needs. This person will complete complex tasks, supervise the work of staff and communicate work progress to top management. This person is expected to demonstrate expertise in the field’s concepts, practices and procedures. The Documentation Manager is expected to rely on extensive experience and judgment to accomplish goals and perform the essential functions and responsibilities of the job.

Essential Functions and Responsibilities:

  • Oversee all documentation activities within the organization for internal and user-focused documentation
  • Work closely with the development team to ensure release notes and user-guides are adequate for user-focused materials
  • Attend required design review meetings, accurately summarize changes, and report to the documentation team any updates/modifications that are needed to documentation materials
  • Work closely with the training department in writing and maintaining the company’s training materials for user-focused materials
  • Assist with developing a strategic plan outlining documentation release plans, including but not limited to documentation specialist’s responsibilities, communications of deliverables and timeliness in delivery of release materials
  • Successfully manage and direct the work of the Documentation team and review the work of documentation staff
  • Manage all documentation related projects and tasks associated with the Company’s SharePoint site
  • Ensure departmental documentation is complete, accurate and up-to-date, and in compliance with quality system and company requirements
  • Define and track documentation metrics
  • Evaluate processes and procedures for effectiveness and efficiency
  • Responsible for assessing training needs and job performance of staff
  • Provide consultation on all documentation projects
    • Ensure continual compliance with Company and Quality System Requirements.  Participate in annual Quality System audit and promptly resolve findings
    • Report regularly on the team projects, goal objectives and performance metrics
    • Cooperate with other departments in the successful development and maintenance of cross team products, services, functions and improvements
    • Train, mentor and serve as a resource to other members of the team and cross-departmental colleagues regarding documentation questions
    • Deliver presentations for customer or client audiences and professional peers as necessary

Perform other related duties as assigned

Requirements

Knowledge, Skills, and Abilities:

  • Strong ability to pay attention to detail
  • Proficient with Microsoft Office (Excel, Outlook, Word)
  • Experience and knowledge of Microsoft SharePoint
  • Experience with pagination, web authoring and graphic design software (InDesign, and MadCap Flare a plus)
  • Proven ability to write clear, concise documentation that is technical in nature on a deadline
  • Ability to keep current in constantly evolving technical advances and computer software
  • Ability  to lead and mentor others
  • Extensive experience with project planning and project management and ability to remain on-task
  • Ability to manage through shifting priorities of a project, team and company
  • Proven ability to conceptualize and correctly evaluate business and/or user requirements and needs
  • Excellent analytical skills, problem solving skills and ability to resolve problems quickly in their entirety
  • Proven ability to communicate clearly and professionally in verbal and written formats with both internal and external customers
  • Ability to follow DI’s policies and procedures
  • Meet location requirements based in South Burlington, Vermont

Education and/or Experience

Bachelor’s Degree and at least seven years working experience in related field, such as, documentation or technical writing at least 10 years related working experience from which comparable knowledge and skills can be acquired. 

Physical Requirements/Working Conditions:
While performing duties of this job, the employee is predominately functioning in a sedentary light office position with high frequency of keyboarding, and computer use.

Preferred skills and experience:

In addition to the above requirements, the ideal employee/candidate will have experience with the following:

  • Technical writing experience related to software products, specifically in the healthcare industry
  • Previous experience managing a team
  • Knowledge of the integration of laboratory information systems, analytical instrumentation and automation systems
  • Experience with InDesign and MadCap Flare
  • Fluent in the French language

Supervision Level

This person reports directly to the Worldwide Director of Research and Development, and is responsible for leading and mentoring others. 

 
 
To apply for Data Innovations - North America positions:

If you are interested in working for a leading laboratory software company, send us your resume today.

 

Benefits of Working for Data Innovations North America

  • Competitive salary
  • Matching 401(k) 
  • Comprehensive, highly-desirable benefit plan including medical, dental, vision, short and long term disability
  • Generous paid time off 

If you are interested in working for a leading laboratory software company, send us your resume today.

Data Innovations LLC is an E-Verify Employer

Equal Opportunity Employer