Senior Software Quality Engineer

hace 1 día

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.

**W**orking 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 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, reviews and support on-time 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 trust-based peer relationships cross-functionally
- Supports and/or leads cross-functional project teams (local or international) related to non-product 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
- 5 - 6 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 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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