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Careers

Ortho2 is the leading provider of practice management, imaging, and communication software to orthodontic professionals.

Open positions: Quality Assurance and Regulatory Affairs Manager, Data Conversion Specialist

Careers

Data Conversion Specialist

Ortho2 is seeking a Data Conversion Specialist, for our Internal Services Department. The Data Conversion Specialist is responsible for the conversion of client data from various legacy systems into our software, as well as developing customized solutions for our existing clients. Our ideal candidate should have the desire to learn, be detail oriented with the ability to meet project timelines.

Responsibilites:

  • • Work closely with our client and our New Customer Care team to understand the client’s needs and develop a plan to meet their expectations and requirements.
  • • Review and evaluate the existing data sources and analyze the conversion steps required.
  • • Create project timelines and communicate with client and team members, assessing progress of deliverables from conception to completion.
  • • Design, develop, revise, and maintain SQL scripts, code, and queries for data translation, conversion, and reporting.
  • • Convert existing data, using ETL processes, creating queries and scripts to manipulate the data into the format needed.
  • • Conduct system testing and provide trouble-shooting to quickly and accurately find solutions to resolve issues.
  • • Communicate with both the customer and internal team members keeping both informed as to potential issues that may affect the timeline.
  • • Provide post conversion issue resolution, inefficiencies and/or recommendations for existing process changes.
  • • Assist in creating customizations to our practice management suite of orthodontic software.

Qualifications and Skills:

  • • Associated degree in Computer Science or related field, Bachelor degree preferred.
  • • 1-2 years of experience working with customers where analytical and technical problem solving was required.
  • • Must possess knowledge of data conversion routines, protocols, and ETL processes.
  • • Knowledge of ETL processes, data migration, data conversion, and/or data integration routines and protocols.
  • • Comfortable importing and exporting database files from multiple sources.
  • • Experience with HTML, SQL, XML, Visual Studio, and Microsoft Suite of products.
  • • Knowledge of C# not required, but would be a plus.
  • • Exposure with both Apple and Android applications.
  • • Demonstrate excellent written and verbal communication skills.
  • • Must be detail oriented with strong organizational skills to multitask projects simultaneously with the ability to commit to and deliver projects on time.

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Benefits Summary

Data Conversion Specialist

Quality Assurance and Regulatory Affairs Manager

Ortho2 is seeking a Quality Assurance and Regulatory Affairs Manager to be based in Ames, Iowa, who will be responsible for planning, directing, and/or coordinating quality and regulatory processes for certain components of our orthodontic software practice management suite of products.

Duties and Responsibilities include, but are not limited to:

  • • Manage the FDA-QSR and ISO 13485 quality system requirements
  • • Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards
  • • Review and monitor controlled records supporting the QMS
  • • Ensure all quality assurance systems and processes are being adhered to
  • • Coordinate preparation for internal and external audits and inspections
  • • Designated Representative (deputy) per FDA-QSR quality system requirements; specifically;
  • • Ensure processes needed for the QMS are maintained and updated as needed
  • • Report to management on the performance of the QMS and any needs for improvement
  • • Ensure the promotion of awareness of regulatory requirements throughout the organization to any employees/stakeholders involved with the regulated products
  • • Coordinate Design Control activities as they relate to FDA-QSR and ISO
  • • Collaborate with internal teams to maintain and track standardized quality training for employees
  • • Ability to wear many “hats” in a small company environment where helping coordinate functions such as Design Control, technical report writing, and risk analysis will be needed
  • • Other duties as assigned

Minimum Education Requirements:

  • • Bachelor’s degree in science, engineering, or technical field preferred.

Job Requirements:

  • • 2-3 years’ experience with Regulatory Affairs activities
  • • Knowledge of the FDA regulatory/quality processes and personal experience in working directly with regulatory and/or safety agencies (e.g., 510Ks, CE, UL, Notified Bodies, etc.)
  • • Experience with FDA, QSR quality systems requirements – ISO experience recommended
  • • Excellent interpersonal, written and verbal communication skills
  • • Experience with software-based product – medical/dental software desirable
  • • Strong computer skills for maintaining an electronic Quality System

Benefit Package:

Ortho2 offers an excellent benefits package, including medical, dental and prescription drug coverage. Paid time-off, short term and long term disability insurance, life insurance and a 401k/Roth plan with a generous company match. As well as the opportunity for a performance based, year-end bonus.

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Benefits Summary

Quality Assurance and Regulatory Affairs Manager

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