Quality Systems Analyst II

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. JOB DESCRIPTION: 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. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. 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 bachelors 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 This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology. The Quality Systems Analyst II will be responsible for owning complaint trend escalation investigations, ensuring that potential product and process issues are thoroughly assessed and effectively managed. This includes applying structured root cause analysis (RCA) methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks with cross-functional partners to identify underlying drivers, validate findings, reach well-supported conclusions for investigations, and implement impactful changes to process and design. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday. What Youll Work On Own complaint investigation activities related to all Abbott Diabetes Care products, ensuring compliance with procedures and timely completion Partner with cross-functional Quality and Business Unit teams to deliver investigation results and implement impactful changes, including but not limited to Prepare and provide relevant reports and analysis in support of internal and external audits. Support company initiatives aligned with the Quality Management System (QMS) and other regulatory requirements. Ensure compliance with FDA and international regulatory requirements, and corporate/divisional policies, procedures, and processes. Perform additional related duties and responsibilities as assigned. Required Qualifications Bachelors degree required. Minimum 3 years of experience in a manufacturing environment; medical device industry experience preferred. Experience conducting investigations in a regulated environment, including CAPA. Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards. Preferred Qualifications Strong ability to manage multiple tasks and priorities in a fast-paced, changing environment. Advanced proficiency with Microsoft Office; experience with SQL is a plus. Strong analytical skills with the ability to query, refine, and summarize data in a visual format. Excellent communication skills, with the ability to interact effectively across multiple functions (Customer Support, R&D, Manufacturing) and at various levels of the organization. Proven ability to work collaboratively within a team and independently as an individual contributor. Strong organizational skills, attention to detail, and ability to meet deadlines. Demonstrated ability to leverage and engage others to accomplish projects. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 Opportunity Employer, committed to employee diversity. Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers. The base pay for this position is $81,500.00 $141,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 1360-1380 South Loop Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: 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) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter