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Sr. Quality Engineer
Little Canada, Minnesota
Contract Position
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Applied on October 24, 2020
Job Id #43696 Posted October 13, 2020


Duties: 

  • Primarily responsible for authoring, reviewing/auditing, and approving project documentation associated with the SDLC to support Corporate, Division, FDA, and other regulatory requirements. 
  • This role is accountable for determining changes or improvements needed to support the QA System and business driven objectives. 
  • In addition to these primary areas of focus, quality assurance will perform project work related to: 
  • Infrastructure (Hardware or Layered Software Installations), Application quality, Compliance initiatives, Validations, Internal / supplier audits, CAPA system investigation, confirmation, or verification.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 
  • Responsible for implementing and maintaining the effectiveness of the quality system. 
  • 1. Accountable for ensuring that project documentation for the software development lifecycle (SDLC) is followed for quality and non-quality applications. 
  • 2. Provides project management for validation or SDLC activities including: Client QA time estimates, Provides software validation / QA guidance to clients and QA team, Organizing validation or SDLC material for library or electronic storage, Coordinate and / or lead validation review board meetings. 
  • 3. Responsible for assessing risk and applying risk based approach strategies without compromising compliance. 
  • 4. Recommend system release readiness and generate key project deliverables that are approved by senior managers and reviewed by regulators. 
  • 5. Responsible for evaluating system (applications, layered software, & hardware) implementations or changes for impact on other systems. 
  • 6. Perform inter- and extra- audits divisional audits against Abbott Polices, Procedures, Processes, Guidelines, etc.? under the guidance of senior QA staff. 
  • 7. Responsible for coordinating, facilitating, and reporting inspections or observations completed for or on CIT. 
  • 8. Recommend modification to CIT quality and non-quality systems and drive changes through the approval process. 
  • 9. Develop and maintain written policies and procedures related to the SDLC. 
  • 10. Perform Quality Engineering function related to process improvements, metrics collection and analysis, and adherence to defined Abbott practices. 

Requirements: 

  • Associates Degree or higher and minimum of 5 years, to include experience in one of the following areas: 
  • Experience in a formal software development life cycle (5-9 years). 
  • Experience in regulated software environment. 
  • (2-3 years) Project Management in software experience (1-2 years)john

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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