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.

About Abbott

Abbott is a global healthcare leader who is creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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 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

The position of Quality Investigation Engineer is within our Infectious Disease Developed Markets business unit located in Scarborough, Maine.

In this role, you will be responsible for supporting the coordination and investigation of nonconformance and corrective and preventive actions (CAPA). The role will provide support for product quality assurance, process improvements, and all quality system programs at the Scarborough Site.

Abbott Rapid Diagnostics 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 crucial information for the treatment and management of diseases and other conditions.

What you'll work on

• Support the Nonconformance (QI) and CAPA program
  • Track Non-Conformance records to ensure the timely closure of all records.
  • Guide owners of investigations on performing investigations and in the use of Root Cause Analysis Tools.
  • Manage corrective and preventive actions to ensure timely closure of actions resulting from various types of investigations.
  • Provide metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.
  • Act as the lead for Non-Conformance impact assessments and investigations as needed.
  • Perform the closure of Effectiveness Checks. Manage the Effective Checks to ensure they are completed by the required due date.
  • Provide training on the use of Agile PLM, on performing investigation, and performing root cause analysis as needed.
• Assist during regulatory inspections or other audits as required.
• Other duties as required.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• BS in Engineering, Chemistry, Bio-Technology, Life Science, or related discipline or equivalent combination of education and experience.
• 3 - 5 years of experience in manufacturing within a regulated industry, preferably within the medical device industry.
• Experience with and understanding of quality management systems, preferably within the medical device industry.
• Excellent quantitative and analytical skills (including use of statistical software).

Preferred

• Familiar with federal and other regulations, e.g. QSR, ISO 13485, CMDR, IVDD/IVDR.
• Familiarity with modern ERP systems, PLM systems, and/or manufacturing documentation (e.g., BOM, item masters, etc.)
• Proficient in using the Agile PLM system.
• Strong analytical, verbal communication, and writing skills.
• Ability to work in a team environment as well as independently and with minimal supervision.
• Ability to communicate in writing clearly and concisely, using grammatically correct sentence structure.
• Skilled in tasks associated with document handling, archiving, and change management.
• Strong attention to detail and accuracy.
• Strong time management, organizational, and prioritization skills.
• Ability to effectively manage multiple projects and priorities.
• Ability to interface professionally at all levels of the organization.

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 equal-opportunity employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.