Associate QA Product Analyst

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.

**Job Title**

**Associate QA Product Analyst**

**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 of which you dream.
+ 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 (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**

We are seeking a Quality Engineer to work at our Temecula, CA location in our Vascular division.

The Associate QA Product Analyst 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.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.

Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

**WHAT YOU’LL DO**

+ 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.
+ Review written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
+ 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.

**EDUCATION AND EXPERIENCE YOU’LL BRING**

**Required Experience**

+ Bachelor's degree or an equivalent combination of education and work experience.
+ 0-2+ years of related work experience
+ 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.

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 $50,000.00 – $100,000.00.

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

Required Skill Profession

Other General