1+ months
2018-05-072018-07-20

Sr QA Professional - Quality Engineering

Abbott
Des Plaines, IL

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The Quality Engineer will be responsible for supporting Operations with CAPA, Investigations, Validation, Change Control and Predictive Monitoring. Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Defines project goals and milestones.

Quality Engineering - Provides solutions to a wide range of difficult problems.  Ensures that solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Defines project goals and milestones. Decisions may have short and long term impact.  Responsible for timely project completion.  Able to contribute functional skills and expertise broadly. Applies solid understanding of quality system elements from product inception through launch. While recognizing project interdependencies and with minimal oversight; leads complex quality discussions across various departments including; as needed; external suppliers.  Acts as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem. Formulates thorough reason and justification for design and document changes. Identifies critical parameters associated with change.  Ensures compliant documentation in area of responsibility.  Receives general direction and exercises considerable discretion to own work detail. 

Communicates confidently and effectively with management; peers; and key stakeholders.  May represent own team while on cross-functional project teams with other functional leaders. Directly influences project direction and scope. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.

Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry.  Ensures adherence and maintains the effectiveness of the Quality System; including the Subsystems and Key processes that govern the area by promptly addressing noncompliance issues.

Ensures evaluation of product safety and efficacy and elevation of risk-based issues. Creates and reviews risk management documentation to reduce or eliminate risk. Makes independent risk-based decisions within defined parameters while assuring that these decisions are aligned with the appropriate quality system.  Authors risk control packages and demonstrates the ability to analyze; evaluate; and control risk decisions by utilizing common practices throughout the quality system. 

Education:

Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related

discipline is required OR relevant combination of education or experience.

Experience:

At least 5 years work experience in Quality or related field experience; Less experience

may be appropriate with advanced degree. Preferred experience in the Healthcare industry.

Has a history of completing successful projects and driving positive compliance outcomes.
Job Family: Operations Quality
Division: AMD Molecular
Travel: No
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Sr QA Professional - Quality Engineering

Abbott
Des Plaines, IL

Share this job

Sr QA Professional - Quality Engineering

Abbott
Des Plaines, IL
US

Separate email addresses with commas

Enter valid email address for sender.

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast