Sr. Quality and Compliance Specialist

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 115,000 colleagues serve people in more than 160 countries.
About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.
We’re always looking towards the future, anticipating changes in medical science and technology.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions.
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity We have an exciting opportunity for a Sr.
Quality and Compliance Specialist within our Abbott Core Diagnostics business located in Irving, TX.
This position will join a team of quality system experts to support the site as a center of excellence in instrument design and manufacturing.
As a Sr.
quality and Compliance Specialist you'll work on compliance, Quality System, and problem solving.
Collaborating across departments, small teams, and large teams to continuously improve the quality of our products and processes.
What You’ll Work On Identify internal requirements and external regulations, guidances, and standards applicable to the site’s quality systems Interpret changes and incorporate them for use in Abbott business processes Identify areas of potential impact within Abbott and educate functional areas on quality system requirements Participate across the business unit to standardize Abbott quality system policies and procedures Review and update the Quality System Manual and applicable Internal Quality Agreements as needed Contribute to the development and maintenance of site inspection readiness plan and support mitigation of site risks as applicable Conduct facility walkthroughs to assess area compliance with site procedures and applicable external regulations and standards Ensure effective implementation of mitigation plan(s) Facilitate internal and external assessments to evaluate the progress of the inspection readiness plan Provide Quality System training as needed, including new hire onboarding and focused training topics as applicable.
Facilitate inspection planning including logistics of front and staging room, facility and SME readiness, and correspondence with inspectors as needed Provide resource and strategy support during internal and external quality system audits including staging room support and Subject Matter Expert as needed Facilitate local completion of internal and external audit requests needed by other ADD sites Cultivate a wide range of internal networks to facilitate completion of quality system improvement projects Provide Quality System expertise to cross-functional teams as needed EDUCATION AND EXPERIENCE YOU’LL BRING IN Required Bachelor’s degree in Life Sciences, Technology, Engineering, or Regulatory Affairs is preferred.
Minimum 5 years experience in Quality Assurance, Quality Control, or Regulatory Affairs Previous experience with regulatory interface and prior audit experience required Working knowledge of ISO/EU standards and FDA Quality System Regulations required History of completing successful projects and driving positive compliance outcomes Ability to work in a dynamic and fast-paced environment Must be a strong communicator with peers, team members, and management Familiarity with In vitro Diagnostic or Hematology products is a plus Previous experience with quality system engineering is a plus * 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 $71,300.
00 – $142,700.
00.
In specific locations, the pay range may vary from the range posted.