Quality Engineer II - Risk Management

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.

As the Quality Engineer II Risk Management, you will Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation.   Perform risk assessments and evaluations for products that conform to established standards and agency regulations.

What You’ll Work On

• Perform risk evaluations associated with post market data, give guidance to risk evaluations for product development.

• Perform Health Hazard Evaluations

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

• Demonstrates 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, and contractors.

• Proactive in finding quality improvements related to Risk Management processes.

Required Qualifications

• Bachelor's degree in engineering or related field

• Minimum 2 years of related work experience

Preferred Qualifications

• Understanding of complaint management and Health Hazard Assessments for on-market (distributed) product

• Medical device, regulatory environment or pharmaceutical manufacturing

• Credentials of a Certified Quality Engineer

• Knowledge of GMP, ISO, FDA regulations, and quality systems auditing

• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

• Strong organizational and follow-up skills, as well as attention to detail

Apply Now

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.

The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.

• risk management
• quality assurance
• regulatory compliance
• project management
• cross-functional collaboration
• health hazard evaluation
• gmp knowledge
• iso standards
• fda regulations
• complaint management
• quality systems auditing
• attention to detail
• leadership skills
• organizational skills
• communication skills
• problem-solving skills
• medical device knowledge
• pharmaceutical manufacturing