Validation Specialist

Title
Validation Specialist
Job ID
2025-14499
Location
ARC-One Remote
Geographic Location
US-
Category
Information Technology

Overview

Responsible for all aspects of verifying and validating a qualified medical device as regulated by the FDA. Reviews user stories with relation to user industry practices and determines risk and impact to product and donor safety.

Responsibilities

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

  • Maintains responsibility for writing BDDs and assisting teams in the creation of automated tests, ensuring user stories have adequate acceptance criteria in relation to industry use and standards.
  • Collaborates with agile teams, Product Managers, and management, to ensure features have been met.
  • Assists teams in PI planning activities
  • Assists teams in the creation and documentation of user stories and their acceptance criteria from a software verification perspective
  • Ensures traceability of tests to user stories is documented
  • Drive the development of required acceptance criteria for user stories
  • Creates BDDs
  • Assists in the creation of automated tests
  • Performs ad-hoc testing throughout the development cycle to provide feedback to developers
  • Reviews results of automated tests for completeness and acceptable results in all applicable environments
  • Assists in ensuring validation activities are documented and executed
  • Validates software via process workflow in a regulated environment
  • Promotes culture of quality and mentors cross-functional teams.

 

Qualifications

Qualifications Required

  • Bachelor’s degree from an accredited college or university
  • Two (2) years of experience in regulated quality assurance or blood bank environment as well as prior software testing experience or an equivalent combination of education, training and/or experience.
  • SAF(e) Agile certification, training, or experience preferred
  • Ability to analyze and document complex business processes as user stories
  • Ability to multi-task and remain flexible when priorities or work direction change
  • Strong analytical and problem-solving skills
  • Ability to explain technical concepts in non-technical terms to customers and teams
  • Ability to analyze user stories and write acceptance criteria
  • Knowledge of SAF(e) Agile software development life cycle principles and quality assurance

Working Conditions

  • Must have reliable internet connection at all times
  • Must be able to travel 10% of the time

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