Senior QA Engineer - Non-Product Software Validation

Abbott (abbottcareers2 board); United States; On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with employer contribution

Tuition reimbursement

Job summary

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation within the Transfusion Medicine Diagnostics Division. You will apply software quality engineering principles to ensure life cycle compliance and improve development efficiency.

Responsibilities include implementing and maintaining the quality system, guiding risk-based investigations, and collaborating with management and external partners to address quality issues and audits.

Qualifications

• Bachelor's degree in Computer science, software engineering, or closely related discipline or equivalent experience.
• Minimum 4 years related work experience in Quality or a related field.
• Knowledge of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Apply established software quality and engineering methods to investigate and solve software quality problems.
• Advises project management and participates in the quality aspects of software projects.
• Helps in the creation and improvement of software development and quality operating procedures.
• May lead in the creation and improvement of software development and quality operating procedures.
• Deals with mid-level management and outside entities in response to quality problems, needed process improvement, and audit observations.
• Reviews predefined deliverables/activities in SWQA processes.
• Apply basic risk management principles to all activities and tasks to investigate non-conformances.

Skills

Software quality engineering

Quality assurance

Risk management

FDA QSR ISO 21 CFR 11

Education

Bachelor's degree in Computer science / software engineering

Master's degree preferred

Job description

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation within the Transfusion Medicine Diagnostics Division. You will apply software quality engineering principles to ensure life cycle compliance and improve development efficiency.

Responsibilities include implementing and maintaining the quality system, guiding risk-based investigations, and collaborating with management and external partners to address quality issues and audits.