Quality Professional – Complaint Investigation, Post-Market Surveillance

Job description

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 103,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Internal Job Title: "Professional, Quality"

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Santa Clara, CA currently has an opportunity for a Quality Professional – Complaint Investigation, Post Market Surveillance.

WHAT YOU’LL DO

Main Purpose:

Investigates complex complaints in a compliant manner to determine if product is performing within specifications by completing a variety of tasks such as reviewing product documentation, tracking and trending data, submitted data, and/or consulting with third parties and performing product testing. Maintains compliant and detailed complaint records.

Responsibilities:

·  Independently determines direction of complaint investigation and interprets data within the guidelines of the procedure.
·  Evaluates the results of the tasks performed for the investigation to draw an investigation conclusion. Communicates and recommends a quality decision, aligning different quality and technical functions on the recommendation. Considers customer expectations.
·  Performs product testing on multiple different hematology instruments with varying functionality according to pre-approved protocols. Product testing includes but is not limited to use of quality control, calibration, and human blood materials to test returned parts, reagents, and other materials.
·  Performs routine maintenance and quality control on Complaint Investigation instruments and documents in accordance with procedures. Some troubleshooting/ service of instruments may be needed.
·  Handles returns from customer sites in accordance with procedures.
·  May participate in audits in a variety of roles as needed.
·  May lead a project with a limited scope, but usually a contributor on broader projects.

Accountability/Scope:

·  Receives general direction and exercises considerable discretion to own work detail. Responsible for determining scope of investigation within the guidelines of the procedure. Evaluates data and information independently to reach investigation conclusion.
·  Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.
·  Decisions may have short- and long-term impact.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

·  Apprenticeship or Bachelor’s Degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.  
·  At least 3 years work 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:

·  Prior experience (3 or more years), as a Medical Technologist or other experience related to Clinical Hematology, from Diagnostics and/or Medical Device companies.
·  Strong technical communication and comprehension skills, both verbal and written.
·  Experience conducting product testing and/or other basic laboratory work .
·  Demonstrated ability to prioritize workload and basic project management skills.

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
·  Pension Plan
·  The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

HEMA Hematology

        

LOCATION:

United States > Santa Clara : 4551 Great America Parkway

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

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