Staff Quality Auditor

1 month ago


Alameda, United States Abbott Laboratories Full time

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. Youâll 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 student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs 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 Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology.

As the Staff Quality Auditor you will be supporting / leading assigned internal audits, supplier audits and external audit processes. You will be supporting / leading the compliance gap management activities including regulatory /standards tracking and other compliance management activities.

What Youâll Work On

  • Lead/support assigned internal/clinical/supplier audits to maintain timely closure of the audit cycles

  • Support Audit Readiness activities for external audits including training staff /guidance in preparation of external audits

  • Support compliance gap management activities e.g. compliance risk management- Identifies risks to the business and resolutions to address compliance gaps.

  • Strategize and prioritize the compliance gaps and track them to the closure

  • Provides guidance to the subject matter experts (SMEs) in closing the compliance gaps

  • Assist management of near miss program

  • Track regulations and industry standards revisions. Evaluate and communicate the impact of these revisions with the related departments and follow up compliance to these revisions.

  • Prepares/ reviews/analyses the metrics data

  • Promotes awareness and understanding of quality & compliance within the division. Provide training to the division to increase compliance awareness

  • Participate/Manage the compliance initiatives and other assigned projects

Required Qualifications

Bachelors Degree in Technical Field - Science or Engineering or an equivalent combination of education and work experience

Minimum 5 years of experience

Quality Assurance, Internal Auditing, Quality Compliance Management or related experience

Preferred Qualifications

Medical device/pharma experience

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

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 $109,300.00 â $218,500.00. In specific locations, the pay range may vary from the range posted.



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