Associate Specialist Quality-Document Control

Abbott • Irving, TX

2d • Onsite

About The Position

This position works out of our Dallas, TX location in the Transfusion Medicine, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Associate Quality Specialist- Document Control is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System.

Requirements

• Bachelors or an equivalent combination of education and work experience.
• Entry level position, in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.

Nice To Haves

• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.
• Knowledge of ISO 13485 standard.
• Knowledge of quality management techniques and application.
• Demonstrated initiative and problem-solving skills.
• Critical-thinking skills.
• Ability or aptitude to use several types of databases and other computer software.
• Knowledge of document lifecycle and version control.
• Strong attention to detail with the ability to manage multiple priorities in a fast-paced environment.
• Strong organizational and communication skills.
• Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Assist in determining quality attributes and requirements.
• May provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Maintain life cycle management systems and/or databases.
• Manage document versioning, approvals, and distribution.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Participate in cross-functional teams.
• Understand and comply with applicable EHS policies, procedures, and guidelines.
• Works under the supervision of more experienced staff who review results for overall accuracy, completeness, and sound judgment.
• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.
• Responsible to meet established objectives and goals.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management.
• Other tasks and duties as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level