Non-product Software Quality Engineer

Abbott

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: The Opportunity This Nonproduct SW Quality Engineer is responsible for ensuring that computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. They help to organize and maintain an inventory of software computerized systems and tools in use to ensure they are in a continued state of validation. They are a key contributor to validation efforts by reviewing quality system documentation as they apply to the development, verification, validation, use, and maintenance of the software or firmware. They independently coordinate activities with other functions and departments to complete validation activities and to see projects through to completion.

Requirements

Bachelor’s Degree, preferably in Engineering, Technical Field, Life Science, or related discipline or an equivalent combination of education and work experience.
2+ years’ experience in a Quality Assurance or software quality engineering experience in a medical device company
Knowledge of FDA QSR, ISO13485, ISO14971, IEC62304 and FDA Computer Systems Validation (CSV).

Nice To Haves

Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus.
ASQ Certifications a plus.

Responsibilities

Provides Quality guidance in direct support of implementation and maintenance of the nonproduct software lifecycles.
Contributes to multiple portions of the Quality System, including but not limited to Master Validation Plans, Impact Assessments, Validation Plans, System Specifications, Requirements, Test Protocols, Test Reports, Trace Matrices, Summary reports, NC/CAPA, and others as needed.
Develops and conducts training of company personnel for the divisional non-product software development and validation program
Completes SWQA tasks in accordance with current Quality System Requirements.
Works independently with objectives given by manager, planning and coordinating own work to high-level project schedules
Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process, Company Policies, or project plans.
Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving issues.
Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC software/firmware products.
Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.