Specialist Quality Assurance - Complaints

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. **JOB DESCRIPTION:** -------------------- **_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._ * _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 a 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 worldwide 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_** _This position works out of our **Dallas, TX** location in the **Core Lab**, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people._  _The **Specialist Quality Assurance** will_ _analyze 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._ **_What You’ll Work On_** * _Conduct investigations related to quality events and customer complaints in compliance with applicable regulations and internal procedures._ * _Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations._ * _Apply clinical knowledge, as related to product application, to evaluate identified complaints._ * _Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis._ * _Composed written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers._ * _Ensure investigation and records are completed accurately, thoroughly, and in accordance with regulatory and quality system requirements._ * _Support audits and inspections by providing documentation and demonstrating compliance with quality system requirements._ * _Utilize root cause analysis tools and problem-solving methodologies to drive continuous improvement and maintain compliance._ * _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._ * _Ensures compliance with 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._ * _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._ * _Participate in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs). Team members helping and interfacing with suppliers to deliver products meeting our quality requirements._ * _Receives general direction and exercises considerable discretion to own work detail. Recommend possible solutions. Provides compliant solutions to a variety of complex problems._ **_Required Qualifications_** * _Bachelors – Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience._ * _Minimum 3 years work_ _experience 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._ * _Experience working within a regulated industry such as medical device, diagnostics, pharmaceutical, biotechnology, or other regulated industries) is a plus._ * _Experience leading or supporting CAPA activities, investigations, root cause analysis, and quality system compliance activities._ * _Knowledge of quality system requirements, risk management principles, and regulatory expectations related to investigations and/or CAPA processes._ * _Excellent written and verbal communications skills._ [**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:** [https://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 [abbott.com](https://www.abbott.com/), on LinkedIn at [https://www.linkedin.com/company/abbott-/](https://www.linkedin.com/company/abbott-/), and on Facebook at [https://www.facebook.com/AbbottCareers](https://www.facebook.com/AbbottCareers). **The base pay for this position is** $68,000.00 – $136,000.00 In specific locations, the pay range may vary from the range posted. **JOB FAMILY:** --------------- Operations Quality **DIVISION:** ------------- CRLB Core Lab **LOCATION:** ------------- United States > Irving : LC-8 **ADDITIONAL LOCATIONS:** ------------------------- **WORK SHIFT:** --------------- Standard **TRAVEL:** ----------- Yes, 5 % of the Time **MEDICAL SURVEILLANCE:** ------------------------- Not Applicable **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), Routine work with chemicals, Work requiring repeated bending, stooping, squatting or kneeling Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO\_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\_Spanish.pdf