Software Quality Engineer Iv

hace 2 semanas

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 best place to work for diversity, working mothers, female executives, and scientists.

**The Opportunity**

This position works out of our Costa Rica - Alajuela location in the EP Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives

As the **Software Quality Engineer IV**, you will design software requirements, protocols, test plans, scripts, and reports to validate non product software, using the non-product software development life cycle procedure, also it will identify, analyze, and document software validations to meet current regulations and medical industry standards. Provides technical guidance and assists on solving problems related to non-product software.

**What You’ll Do**
- Support customers on non-product software validations for accuracy, adequacy, and compliance with the non-product software development lifecycle, Quality System, Part 11, Data Integrity, Cybersecurity and FDA regulations.
- Execute, review and support on-time completion of Software Quality Engineering deliverables: software requirements, validation test plans, code reviews, test scripts, test reports, software inventory reports
- Support cross-functional project teams (local or international) related to non-product software and quality improvements.
- Support cross-functional project teams (local or international) related to non-product software and quality improvements.
- Can perform other assignments according to the requirements of the business or upper management.

**Required Qualifications**
- Bachelor's degree in Engineering, Science or Technical Field.
- 3 - 4 years of experience in Quality Engineering positions.
- At least 3 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 on product and process qualification and validation.
- Advance Commands of English (capable of maintain fluent oral communication face to face or by conference).
- ** Availability to work in Shift B.**

**Preferred Qualifications**
- 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 non-product software validation.
- Knowledge of cybersecurity for medical devices and/or non-product software.
- Knowledge of data integrity and ALCOA+ principles for medical device software and non-product 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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