Senior Software Quality Engineer

hace 2 semanas

Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

You will have access to:

  • Career development with an international company where you can grow the career you dream of
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a the best place to work for diversity, working mothers, female executives, and scientists.

The position

What You'll Do

  • Supports customers on nonproduct software validations for accuracy, adequacy, and compliance with the nonproduct software development lifecycle, Quality System, Part 11, Data Integrity, Cybersecurity and FDA regulations
  • Execute, reviews and support ontime completion of Software Quality Engineering deliverables: software requirements, validation test plans, code reviews, test scripts, test reports, software inventory reports
  • Manage and leads test planning and execution efforts by a combined, team of testers located onsite and/or offshore
  • Establishing & maintain strong trustbased peer relationships crossfunctionally
  • Supports and/or leads crossfunctional project teams (local or international) related to nonproduct software and quality improvements
  • Based on key performance indicators data, may support activities focused on maintaining indicators under control for CTQ, budget or other indicators deemed necessary
  • Represents the SW QE department on a CAPA investigation teams and can lead high complexity root cause issue investigations related to software
  • Provides guidance, leads, supports development and retention of other software quality engineers
  • Serves as the primary site representative for external regulatory inspections and audits in case of absence of a Software Quality Engineer Lead, Software Quality Manager, or higher representative rank in relation to non
- product software related audits

  • Can perform other assignments according to the requirements of the business or upper management

_ QUALIFICATIONS_

_ Experience/Background_

  • Bachelor's degree in Engineering, Science or Technical Field
years experience in Quality Engineering positions

  • At least 5 years of experience in Quality or Manufacturing Engineering positions.
  • Knowledge of statistical/data analysis and report writing experience.
  • Experience working on FDA, GMP, and ISO 13485 Regulated environments.
  • Knowledge of product and process qualification and validation

_ Language Proficiency_

  • Fully Bilingual (English and Spanish)
  • Capable of maintaining fluent oral communication face to face or by conference.

_ Preferred Qualifications__ & Education _**- FDA Class II or Class III medical device experience, preferred

  • Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CSQE) preferred.
  • Ability to travel to support domestic and international manufacturing sites (up to 15%).
  • Knowledge of software validation for medical devices and/or nonproduct software validation
  • Knowledge of cybersecurity for medical devices and/or nonproduct software
  • Knowledge of data integrity and ALCOA+ principles for medical device software and nonproduct software


Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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