Quality Engineer Location & Shift Works out of our Barceloneta location in the Abbott Vascular division. Shift: First shift (Monday to Friday). Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identify manufacturing process defects (scrap, nonconforming material, customer complaints), disposition non-conforming material, and lead identification of primary root causes for basic investigations. Support line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present. Determine initial bracketing and containment, and initiate exception management process. Own basic to moderate exception/CAPA activities without oversight. Work with process owner to bound product stops and document release criteria. Perform lot‑to‑lot yield and rework evaluation. Report quality metrics. Understand product quality plans, documents, and quality systems. Develop product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. Own and maintain product risk analyses and FMEAs. Monitor process by using process monitoring tools and Infinity QS to reduce process variation. Become familiar with Product/Process improvement efforts by understanding current quality metric data and learning analysis methods. Understand Quality Tools & Training Materials and help others gain knowledge of prevalent tools. Lead Product/Process improvement efforts (e.g., scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and using appropriate analysis methods. Run routine problem‑solving investigations without oversight and use Six Sigma tools. Implement minor and major changes through change management system and provide quality engineering impact assessment for changes implemented by other functional areas. Write protocols and reports with management oversight to support engineering studies and validations. Required Qualifications B.S. in engineering discipline. 2 years of experience in Quality and/or Compliance, preferably in medical device industry. Preferred Qualifications Knowledge of applicable US and non‑US regulations. Knowledge and proficiency in the application and principles of Quality Engineering. Ability to effectively communicate cross‑functionally to resolve Quality issues. Excellent written, verbal and interpersonal communication skills in both English and Spanish. Ability to interact effectively with all levels of employees. Benefits Career development with an international company. Health Insurance (starting on Day 1 of employment), 401(k) savings plan with company match, life insurance for you and your spouse/children, short‑term disability, long‑term disability. Education assistance, employee assistance program, vacation, sick leave, personal days. Recognized as a great place to work in dozens of countries and named one of the most admired companies by Fortune. Recognized as one of the best big companies to work for, and a best place to work for diversity, working mothers, female executives, and scientists. Compensation The base pay for this position is $54,300.00 – $109,000.00. In specific locations, the pay range may vary from the range posted. Equal Opportunity Employer Statement Abbott is an Equal Opportunity Employer, committed to employee diversity. #J-18808-Ljbffr