Associate Product QA Specialist
Company: Abbott
Location: Temecula
Posted on: April 26, 2024
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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 114,000 colleagues
serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for
yourself and family, be your true self and live a full life.
You'll also have access to:
Career development with an international company where you can grow
the career you dream of .
Free medical coverage for employees* via the Health Investment Plan
(HIP) PPO
An excellent retirement savings plan with high employer
contribution
Tuition reimbursement, the Freedom 2 Save
(https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html)
student debt program and FreeU
(https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html)
education benefit - an affordable and convenient path to getting a
bachelor's degree.
A company recognized as a great place to work in dozens of
countries around the world and named one of the most admired
companies in the world by Fortune.
A company that is recognized as one of the best big companies to
work for as well as a best place to work for diversity, working
mothers, female executives, and scientists.
The Opportunity
This position works out of our Temecula, CA location in the Abbott
Vascular Division. Our medical devices help more than 10,000 people
have healthier hearts, improve quality of life for thousands of
people living with chronic pain and movement disorders, and
liberate more than 500,000 people with diabetes from routine
---ngersticks. Abbott Vascular provides innovative, minimally
invasive, and cost-effective products for treatment of vascular
disease.
Our location in Temecula, CA currently has an opportunity for a
Associate Product QA Specialist
THIS IS AN ONSITE DAILY POSITION.
MAIN PURPOSE OF ROLE
Analyzes customer complaints to determine which are regulatory
reportable and coordinates activities with internal, field, and end
use customers. Responsible for adherence to Good Manufacturing
Practices (GMPs) and proper complaint handling per the Code of
Federal Register (CFR) and other governmental regulations.
Communicates event investigation results via regulatory reports and
written communications, as appropriate.
MAIN RESPONSIBILITIES
Review complaint communications and assess for regulatory
compliance, reportability, and potential impact to patient safety
and business operations.
Participate in development and modification of these decision
models with changes in product advances/therapies to uphold
consistent compliance with government-mandated regulations.
Evaluate and investigate identified complaints by gathering
sufficient data from clinical staff, field representatives,
internal employees, and laboratory analysis.
Collect, compile, and document regulatory reportability decisions
using event investigation and regulatory decision models.
Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other
regulatory reports, ensuring timely transmission to the appropriate
regulatory authorities.
Apply codes to events to facilitate product performance
records.
Review coding and investigations with engineering, laboratory, and
other internal staff.
Draft written communications detailing the clinical observation,
investigation and/or product analysis, and corrective actions, as
applicable, to physician and other end use customers.
Communications include determination/eligibility for warranty
credit or unreimbursed medical payments.
Begins establishing and cultivating a network of internal resources
to facilitate completion of tasks.
Individual influence is typically exerted at the peer level.
Completes daily work to meet established schedule with guidance
from supervisor on prioritization of tasks.
May exercise authority within pre-established limits and
approval.
Failure to achieve results can normally be overcome without serious
effect on the business.
QUALIFICATIONS
Education
Bachelors Degree Required
Experience/Background
0-2 years of related work experience with a basic understanding of
specified functional area.
General knowledge and basic application of business concepts,
procedures and practices.
Will perform this job in a quality system environment.
Failure to adequately perform tasks can result in noncompliance
with governmental regulations.
Learns to use professional concepts and company policies and
procedures to solve routine problems.
Works on problems of limited scope.
Minimal independent decision making.
WHAT WE OFFER :
At Abbott, you can have a good job that can grow into a great
career. We offer:
A fast-paced work environment where your safety is our priority
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 history of being actively involved in local
communities
Apply Now (https://www.jobs.abbott/us/en)
Learn more about our health and wellness benefits, which provide
the security to help you and your family live full lives:
www.abbottbenefits.com
(http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities
with a company that can help you build your future and live your
best life.
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.
The base pay for this position is $48,000.00 - $96,000.00. In
specific locations, the pay range may vary from the range
posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with
disabilities.
To request accommodation, please call 224-667-4913 or email
corpjat@abbott.com
Keywords: Abbott, Corona , Associate Product QA Specialist, Other , Temecula, California
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