Quality Engineer Ii - Medical Device

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

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:

• 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.
• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• An excellent retirement savings plan with high employer contribution

The Opportunity

This position works out of our Santa Clara, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Quality Engineer II, you’ll have the chance to conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.

What You’ll Work On

• Provides supporting information for change including reasons and justifications.
• Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g.FMEAs).
• Quality System Compliance -Maintains awareness of standards that regulate our industry.
• Ensures compliant documentation related to area of responsibility.
• Participates in the development or modification of Risk management files.
• May lead a project with a limited scope, but usually a contributor on broader projects.
• Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
• Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
• Design Control / Documentation & Change Control - Identifies areas for process improvement.
• Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
• Complaint Evaluation - Investigates complex complaints with management oversight.
• Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
• Provides compliant solutions to a variety of problems of moderate scope and complexity.
• Quality Engineering - Coordinates quality decisions between different quality and engineering groups.
• Provides guidance to other Professionals and Technicians.
• Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Interacts constructively with employees, managers and cross-functional peers.
• Risk Management - Applies basic Risk Management principles to work.
• Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Provides compliant solutions to a variety of complex problems.
• Decisions may have short and long term impact.

Required Qualifications

• Demonstrates technical and business competencies that drive results and continuous improvement.
• At least 3 years work experience in Quality role within Medical Device industry.
• Bachelors Degree in Life Science, Engineering, or closely related discipline.
• Demonstrates understanding of how their function supports the business.

Apply Now

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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

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.

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