Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Software Quality Assurance Engineer will perform software and hardware testing, validation, and troubleshooting activities to ensure compliance with internal and external regulations, while promoting continuous quality improvement.
Work may involve collaborating with cross-functional teams developing and executing tests, performing root cause analysis, and participating in investigations. Also, making presentations to internal/external customers, vendors, and senior management.
Perform software testing activities for the Manufacturing Software Engineering team.
Develop software validation strategies.
Write and execute software validation protocols.
Assist in troubleshooting production floor issues, such as software defects and hardware malfunctions.
Provide recommendations for software/process improvements.
Helps establish processes based on product specifications.
Perform software and hardware configuration activities according to provided specifications.
Assist in software deployments.
Work with cross-functional teams through all stages of the software development process.
Evaluates process and design alternatives based on 'design for manufacturability' principles.
Manages program compliance with 'Quality Control' requirements (i.e. Design Control, Process validation etc.).
Understands IP issues relative to processes being developed.
Maintain breadth of knowledge about manufacturing hardware and software systems and new developments in manufacturing and design technologies.
Effectively communicates moderately complex technical issues and solutions to non-technical internal and external customers.
Exercises technical judgment in planning, organizing, performing, and/or coordinating engineering work. Remains abreast of and consults on technical advancements.
Identifies and routinely uses the most effective, cost-efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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.
Qualification
Required
Bachelor's degree in engineering or an equivalent combination of education and work experience
Minimum 2 - 4 years related experience, preferably in a medical device environment
Preferred
3+ years of experience in software testing
Experience with the manufacture or design of electro products
Operational experience in a medical device manufacturing environment
Familiarity with a variety of software testing concepts, practices, and procedures
MS Office (Excel, PowerPoint, and Word) skills
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Benefits
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Abbott is a healthcare company that is engaged in pharmaceuticals and manufacturing healthcare products.
