Software Quality Engineer II

Job Description

We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures.

• Work with R&D in the completion of system/software requirements and other verification and validation processes related to embedded software products.
• Participate in reviews for Software requirements with ability to interpret and review system design (hardware, firmware, software) and provide useful feedback.
• Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time completion of Quality Engineering deliverables: test plans, test scripts (manual and automated), test reports.
• Identifies parameters, structure, and critical test components. Writes, updates, or executes test design, cases, as well as procedures and reports results.
• Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
• Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks.
• Follow approved Design Control procedures for software development in accordance with FDA guidelines.
• Contributes to and supports root-cause analysis of failures. Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues.
• Support internal (corporate and divisional) and external quality audit.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Readily adjusts priorities and works within team environment for timely completion of common objectives for multiple projects.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Bachelors Degree Engineering or Technical Field(Electrical/Computer Engineering preferred) Or an equivalent combination of education and work experience
• Minimum 2 years
• Software Quality Engineering experience
• Prior medical device experience preferred.
• Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred.
• Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred.
• Programming experience in C/C++/C#, Scripting Language such as Python.
• Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla.
• Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills. ASQ CSQE certification desired.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.