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 Title

Associate Quality Incident Analyst

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.

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. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.
• 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 Arecibo location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Shift: First shift, Monday to Friday

As Associate Quality Incident Analyst, you will be responsible to conduct, Complaints and CAPA investigations with the objective of identifying the root cause(s) analysis of the non-conformance situation being investigated. Provides technical guidance towards the identification of the causes for non-conformances and process' failures, and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.

What You’ll Do

• Conduct/ document in depth and effective failure investigations and DHRs reviews including the implementation of corrective and preventive actions.
• Provides guidance or assist other lead investigators to assure causes of non-conformance are identified, understood and that appropriate corrective/preventive actions are implemented including providing training on tools for process evaluation.
• Reviews and analyses quality trends with the manufacturing/quality teams to recommend and implement appropriate corrective actions. Evaluate and implemented corrective and preventive actions against trends to assess effectiveness of the same.
• Perform and maintain the failure investigation files and the trends preparation and presentation for management meetings.
• Support compliance department activities such as: Quality audits, CAPAs, QDRs and readiness.
• Understand work environment issues such as OSHA regulations, FDA Quality Systems regulations and ISO requirements.
• Understand work environment issues such as OSHA regulations, FDA Quality Systems regulations and ISO requirements.
• Ensure compliance with all SJM procedures and all applicable regulatory agency requirements.
• Other duties as assigned.

Required Qualifications

• Bachelor’s Degree.
• Minimum 1 year of experience In the QSR/ISO – regulated medical device operation.
• Advance computer skills and use of software application(s).
• Knowledge in Technical Writing
• Proficient in the preparation of failure investigations, technical reports and presentations.
• Excellent communication (oral and writing) and interpersonal skills.
• Requires good networking and negotiation skills with varied cultures.
• Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland.
• Must be fully bilingual Spanish/English.

Apply Now

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.

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