Position Overview

Assist/execute Software validation for Quality Management Systems or Production Software. Job duties:
  • Follow SW validation procedure(s) to accomplish software validation or revalidation for Quality Management System (QMS) or Production Software (Equipment or Non-Equipment).
  • Collaborate with business process owners to develop specifications for systems to meet business requirements.
  • Generate user and functional requirements for software projects.
  • Generate master validation plans for software projects.
  • Generate/assist with risk assessments for software projects.
  • Develop test scripts to generate software validation protocols (Operation/Performance qualification protocols).
  • Coordinate user acceptance testing (UAT) activities and execution of validation protocols.
  • Generate software validation reports to summarize the results of the software validation (verify test scripts are successfully completed and tested).
  • Generate deviations reports and resolutions of any deviation if required.
  • Generate traceability matrix and verify all requirements are tested.
  • Execute training material and work instructions for users.
  • Perform additional duties as assigned.
    1. Advanced student with bachelor’s degree in Engineering or other relevant discipline or equivalent combination of education and experience.
    2. Experience in medical device manufacturing.
    3. Written and verbal English proficiency (80-85%).
    4. Knowledge of General Principles of Software Validation (GPSV).
    Desired Qualifications
    1. Ability to translate regulation requirements into practical validation plans.
    2. Ability to write validation documentation (e.g., validation plan, risk assessment, user/functional requirements, protocols, reports, work instructions, etc.).
    3. Keep abreast with regulatory requirements related to QMS software and production (non-equipment or equipment) software.
    4. Experience working independently, effectively, and confidently in a team environment.
    5. Demonstrate assertiveness and collaboration skills.
    6. Show strong decision making and problem-solving skills.
    7. Excellent written and verbal communication skills.
    8. Proficient with MS Project, Word, Excel, Outlook.