Engineer II Software Quality

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity

This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division.

What Youll Work On :

• Develop and conduct training of company personnel for the divisional software development and validation program.
• Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
• Create and execute or direct software validation protocols traceable to system/software requirements.
• 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.
• Design and implement various product and process improvement methodologies (i.e Six Sigma and Lean Manufacturing).
• Apply sound systematic problem solving methodologies in identifying prioritizing communicating and resolving issues.
• Software scoping and Part 11 audits.
• 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.

Required Qualifications

• Bachelors Degree in an Engineering discipline (Computer Science Electrical Mechanical Software) or related discipline.
• Detailed knowledge of FDA GMP IEEE 1012 and ISO 13485.
• Advanced computer skills including statistical/data analysis and report writing.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• 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.
• Ability to travel including internationally.

Preferred Qualifications

• Advanced level degree in an Engineering discipline (Biomedical Systems Electrical Mechanical Software) or related discipline
• Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

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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