Quality Engineer II, Risk Management

Abbott • San Diego, CA

1d

About The Position

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

Requirements

• Bachelors’ degree in Engineering or related field or an equivalent combination of education and work experience
• 2 years’ experience working in a broader enterprise/cross-division business environment.
• Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
• Must possess good communication and analytical skills.
• Ability to work under deadlines.
• 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.
• Demonstrates technical leadership within the department and outside the department.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong organizational and follow-up skills, as well as attention to detail.

Responsibilities

• Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
• Proactive in finding quality improvements related to Risk Management processes.
• Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation.
• Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
• 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, and contractors.
• Proactive in finding quality improvements related to Risk Management processes.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees