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Quality Engineer II, Risk Management

2 months ago

Pleasanton, United States Abbott Laboratories Full time

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.

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

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.

MAIN RESPONSIBILITIES

⢠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.

Education

Education Level

Bachelors Degree (± 16 years)

Major/Field of Study

In Engineering or related field.

Or

Education Level

an equivalent combination of education and work experience

Experience/Background

Experience

Minimum 2 years

Experience Details

Preferably in an Implantable Medical device, regulatory environment or pharmaceutical manufacturing. Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) product.

Credentials of a Certified Quality Engineer are a plus.

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.

Ability to travel, including internationally.



The base pay for this position is $65,900.00 â $131,900.00. In specific locations, the pay range may vary from the range posted.