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Abbott

Design QA Specialist

Posted 10 Days Ago
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Des Plaines, IL
67K-133K Annually
Mid level
Des Plaines, IL
67K-133K Annually
Mid level
The Design QA Specialist ensures compliance with quality standards, coordinates quality decisions, investigates complaints, and supports risk management and documentation processes.
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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.

     

JOB DESCRIPTION:

The Opportunity

The position of Design QA Specialist in Des Plaines IL, will conduct quality-related activities to deliver consistent, high-quality documents, services, products and processes, which adds value to the business.

What You'll Do

  • Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
  • Provides compliant solutions to a variety of problems of moderate scope and complexity.
  • Interacts constructively with employees, managers and cross-functional peers.
  • May lead a project with a limited scope, but usually a contributor on broader projects.
  • Provides guidance to other Professionals and Technicians.
  • Quality System Compliance -Maintains awareness of standards that regulate our industry.
  • Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
  • Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
  • Risk Management - Applies basic Risk Management principles to work.
  • Participates in the development or modification of Risk management files.
  • Complaint Evaluation - Investigates complex complaints with management oversight.
  • Ensures compliant documentation related to area of responsibility.
  • Design Control / Documentation & Change Control - Identifies areas for process improvement.
  • Provides supporting information for change including reasons and justifications.
  • Quality Engineering - Coordinates quality decisions between different quality and engineering groups.
  • Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g.
  • FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
  • Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Provides compliant solutions to a variety of complex problems.
  • Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
  • Decisions may have short and long term impact.
     

Required Qualifications

  • Bachelors Degree (± 16 years): Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline or an equivalent combination of education and work experience
  • Minimum 3 years experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
  • Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.

Preferred Qualifications

  • Preferred experience in the Healthcare industry
  • experience with IVDR products, instrument systems and associated software.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance.

  • Financial security through competitive compensation, incentives, and retirement plans.

  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs.

  • Paid time off.

  • 401(k) retirement savings with a generous company match.

  • The stability of a company with a record of strong financial performance and a history of being actively involved in local communities.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. 

 

We provide reasonable accommodation to qualified individuals with disabilities. 

     

The base pay for this position is

$66,700.00 – $133,300.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:Operations Quality

     

DIVISION:AMD Molecular

        

LOCATION:United States > Des Plaines : DP01

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:Standard

     

TRAVEL:No

     

MEDICAL SURVEILLANCE:Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Top Skills

Design Control
Documentation Control
Ivdr Products
Quality Management Systems
Risk Management

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