Senior Software Quality Engineer

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.

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You’ll Also Have Access To

• 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 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.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity

This position is based out of Sylmar, California.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

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

What You'll Work On

• Act as the Quality representative on design projects, supporting new product introductions, software development and maintenance.
• Documentation: Develop and maintain documentation in compliance with FDA, ISO, and other regulatory requirements. Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues.
• Validation: Create and execute or direct software validation protocols traceable to system/software requirements.
• Change Management: Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Approve engineering change notices and manage customer complaints.
• Risk Analysis: Participate, maintain and assist in completion of risk analysis initiatives for Software related risks.
• Corrective Actions: Support implementation of effective corrective and preventive actions (CAPA).
• Audits: Participate and support internal, regulatory agency and customer audits.
• Continuous Improvement: Champion continuous improvement through the CAPA system and key performance indicators.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Compliance: Ensure compliance 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.
• 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.
  
  

Required Qualifications/Experience

• Bachelors Degree (± 16 years) in an Engineering or Technical Field (or) an equivalent combination of education and work experience.
• Minimum 7 years of Software Quality Engineering experience.
• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including tatistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired.
• 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 approximately 5-25%, including internationally.

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.