Specialist, Quality Assurance

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.<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><p><b>Working at Abbott </b></p><div><div><p>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:</p><ul><li>Career development with an international company where you can grow the career you dream of.</li><li>Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.</li><li>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.</li><li>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.</li><li>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.</li></ul><p></p><p><b>The Opportunity </b></p><p><span>Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is 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.</span></p><p></p><p>Our Core Lab team is looking for a <b>Specialist, Quality Assurance </b>out of our <b>Irving, TX </b>office. They are responsible for administrative and tactical activities that support the effective operation of the Quality Assurance function and overall Quality System. This role within the Operations Quality organization ensures the accurate execution of documentation, system transactions, containment activities, and product review and approval processes, contributing to efficient operations and the delivery of high‑quality products.</p><p></p></div><div><p><b>Responsibilities </b></p><ul><li><p>Responsible for implementing and maintaining the effectiveness of the Quality System.</p></li><li><p>Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.</p></li><li><p>Assist in determining quality attributes and requirements. may provide technical assistance.</p></li><li><p>Utilize quality management techniques to perform investigations and facilitate solutions.</p></li><li><p>Responsible for completing documentation in a timely manner and in accordance with business standards.</p></li><li><p>Participate on cross-functional teams.</p></li><li><p>Other tasks and duties as assigned.</p></li><li><p>Understand and comply with applicable EHS policies, procedures and guidelines.</p></li><li><p>Works under the supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment.</p></li><li><p>Recognizes risks versus the relative gains associated with actions; understands a project&#39;s critical success factors and makes recommendations and decisions impacting those factors.</p></li><li><p>Responsible to meet established objectives and goals.</p></li><li><p>Drives functional performance to ensure that cross-functional standards and expectations are met.</p></li><li><p>May assist in the training of personnel as directed by management.</p></li></ul><p></p><p><b>Education and Experience </b></p><ul><li><p>Bachelor&#39;s Degree OR equivalent combination of education and experience.</p></li><li><p><span>Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position. </span></p></li><li><p><span>Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.</span></p></li><li><p><span>Knowledge of ISO 13485 standard.</span></p></li><li><p><span>Knowledge of quality management techniques and application.</span></p></li><li><p><span>Ability to clearly, concisely and accurately convey communications.</span></p></li><li><p><span>Ability to form and develop interpersonal, professional relationships.</span></p></li><li><p><span>Display socially and professionally appropriate behavior.</span></p></li><li><p><span>Ability to work independently and in groups.</span></p></li><li><p><span>Ability to work cross-functionally.</span></p></li><li><p><span>Demonstrated initiative and problem-solving skills.</span></p></li><li><p><span>Critical-thinking skills.</span></p></li><li><p><span>Ability or aptitude to use various types of databases and other computer software.</span></p></li><li><p><span>Strong organizational skills.</span></p></li><li><p><span>Ability to prioritize.</span></p></li><li><p><span>Ability to multitask.</span></p></li><li><p><span>Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.</span></p></li><li><p><span>Ability to quickly gain knowledge, understanding or skills and is willing to learn.</span></p></li></ul><p></p><p></p><p><a href="https://www.jobs.abbott/us/en" target="_blank"><b>Apply Now</b></a></p><p><b>Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:</b> <a href="http://www.abbottbenefits.com/pages/candidate.aspx" target="_blank"><span>https://abbottbenefits.com/</span></a></p><p>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.</p><p>Connect with us at <a href="https://www.abbott.com/" target="_blank">abbott.com</a>, on LinkedIn at <a href="https://www.linkedin.com/company/abbott-/" target="_blank"><span>https://www.linkedin.com/company/abbott-/</span></a>, and on Facebook at <a href="https://www.facebook.com/AbbottCareers" target="_blank"><span>https://www.facebook.com/AbbottCareers</span></a>.</p></div></div><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>$50,700.00 – $101,300.00<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Operations Quality<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>CRLB Core Lab<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>United States &gt; Irving : LC-8<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>No<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>No<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p>Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.<p style="text-align:inherit">     </p>EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf<p style="text-align:inherit">     </p>EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf