Software Quality Engineer III
abbot
Alajuela, Costa Rica
hace 5 horas

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role. The Software Validation Engineer III role will work closely with the quality and engineering personnel and various project teams throughout the organization and across multiple sites.

In this role, you will help provide regulatory guidance and perform validation duties to ensure all Non product software validation projects and corresponding deliverables adhere to current regulations, industry standards.

MAIN RESPONSIBILITIES

  • Perform ongoing SW validation activities.
  • Assists in the development and execution of validation deliverables.
  • Complete validation and validation related paperwork timely and accurately.
  • Contribute to the growth and development of the software team related to validation best practices.
  • Generate reports and metrics as assigned
  • Support quality / manufacturing engineers for their validation need in manufacturing, labs, facility, utility and other departments.
  • Responsible for implementing and maintaining the effectiveness of the Quality System.
  • Monitor executions for Validation plan.
  • Document work status and report to management frequently.
  • Within structure, plan own work, manage several / often concurrent, tasks to accomplish assigned tasks to meet or exceed expectations (cost, quality, time).
  • Help provide regulatory guidance to ensure all software validation projects and corresponding deliverables adhere to current regulations
  • Prepare and communicate recommendations and respective action plans.
  • Comply with all regulations and standards for quality, Environment, Health, Safety and Energy (EHS&E) Global Policies, Abbott Engineering Standards, and other governance areas as applicable.
  • Ensure quality and effectiveness of assigned tasks.
  • Identify areas of risk with respect to compliance.
  • Offer suggestions to others on how to modify existing process or procedures to improve quality.
  • Assist in development of procedures and standards.
  • Assist in audit.
  • Recognize risks versus the relative gains associated with actions; understand projects. Responsible to meeting established objectives and goals.
  • QUALIFICATIONS

  • Bachelor Degree required Engineering 3 - 4 years experience in Quality Engineering positions
  • At least 3 years of experience in Quality or Manufacturing Engineering positions.
  • Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
  • Knowledge of statistical / data analysis and report writing experience.
  • Experience working on FDA, GMP, and ISO 13485 Regulated environments.
  • Knowledge on product and process qualification and validation
  • Language Proficiency Intermediate command of English. Capable of maintain fluent oral communication face to face or by conference.
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