Product Quality Analyst II

Job Description

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 107,000 colleagues serve people in more than 160 countries

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 important information for treatment and management of diseases and other conditions. The position of Product Quality Analyst II is within our Cardiometabolic business unit located at Alere San Diego in San Diego, California. This role will focus on cardio metabolic diseases, infectious diseases and toxicology. RESPONSIBILITIES: - Process and investigate customer complaints to determine root cause(s). - Ensure accurate documentation of the complaint evaluation and investigation results within assigned complaint records. Maintain good documentation practices (GDP). - Review complaint investigations for accuracy and completeness. - Support trending and analysis of complaint data to ensure appropriate actions are taken. - Escalates potential product performance issues or quality system issues. - Perform specialized tasks as trained in an independent fashion, requiring minimal direction, once procedures are established. - Initiate communication with related staff and functional groups as necessary to complete investigations. - Work involving blood or other potentially infectious materials may be required. - Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities - Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships - Carries out duties in compliance with established business policies - Other duties as assigned, according to the changing needs of the business MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE: - BA/BS in biology, chemistry, physics or related field with laboratory coursework directly applicable to duties or equivalent work experience. PREFERRED QUALIFICATIONS: - A minimum of two to four years in complaint investigation procedures. - Demonstrated skills in carrying out laboratory/research assignments with general guidance in an accurate, effective manner. - Able to work with a variety of people on multiple tasks. - Knowledge and ability to use electronic complaint systems, MS Office - Excellent written and verbal communication skills. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department. About Abbott 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 103,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.