Senior Quality Engineer Risk Management

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.

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. 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 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.

• 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 works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

This role is responsible for developing and maintaining quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element.

• Interprets regulations and requirements to lead, coach, and mentor teams on Risk Management.

• SME for domestic/international sites and affiliates regarding Risk Management Quality System element.

• Works cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation.

• Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.

• Perform Health Hazard and Regulatory Risk Evaluations.

Required Qualifications

• Bachelor's degree in engineering or Technical Field

• 5+ years in related work experience

• Risk management (ISO 14971)

Preferred Qualifications

• Experience working in a broader enterprise/cross-division business unit model

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment

• Knowledge of IEC60601-1 or electrical safety

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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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.