Quality Professional, Validation
Quality Professional, Validation
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$ 66700 - 133300
1 Vacancy
Job Description
JOB DESCRIPTION:
Professional Quality Validation
About Abbott
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.
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. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
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 high employer contribution
Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors 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 Dallas TX location in the Transfusion Medicine business. Our diagnostic solutions are used in hospitals laboratories and clinics around the globe. The crucial information derived from our tests instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As the Professional Quality Validation youll conduct quality-related activities to deliver consistent high-quality documents services products and processes which adds value to the business.
What Youll Work On
Ensure that facilities utilities and equipment (FUE) used in the support of the Quality System are developed validated and maintained in compliance with regulatory and corporate requirements.
Coordinate validation activities with other engineering disciplines departments and contractors.
Estimate plan and review own and others work products.
Review documentation for accuracy clarity consistency completeness and compliance for multiple projects. Plans and performs assignments with a wide degree of difficulty.
Analyze data procedures and requirements with consideration given to financial and business outcomes.
Coordinate activities across impacted groups. Accepts ownership and responsibility for decisions.
Youll be accountable for ensuring that FUE systems used in the support of the Quality System are developed validated and maintained in compliance with regulatory and corporate requirements.
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.
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).
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
Apprenticeship or bachelors degree in Life Science Engineering or closely related discipline Or and equivalent combination of education and work experience.
Minimum 3 years experience working in quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications
Demonstrates understanding of how their function supports the business.
Demonstrates technical and business competencies that drive results and continuous improvement.
Knowledgeable of FDA Quality System Regulations (QSR) Medical Device Directive ISO guidelines and 21 CFR Part 11/Annex 11.
Project experience in validation testing practices methodologies and techniques particularly in testing medical devices or experience leading test engineer team is a plus.
Must have excellent oral and written communication skills.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$66700.00 $133300.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
TM Transfusion Medicine
LOCATION:
United States > Irving : LC-02
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
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) Work requiring repeated bending stooping squatting or kneelingAbbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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