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: Quality Systems Analyst II 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 The Quality Systems Analyst II will be responsible for supporting trend escalations, ensuring that potential product or 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 to identify underlying drivers, validate findings, and reach well-supported conclusions for investigations. 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 Support complaint investigation activities related to glucose meters, ensuring compliance with procedures and timely completion. Partner with cross-functional Quality and Business Unit teams to deliver required reporting, including but not limited to: Complaints trending and summaries FDA Medical Device Reporting (MDR) trending and summaries EU Medical Device Vigilance trending and summaries Weekly, monthly, and quarterly product line complaint reports Prepare and provide relevant reports and analysis in support of internal and external audits. Support company initiatives aligned with the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements. Ensure compliance with FDA regulations, 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 complaint investigations in a regulated environment. 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. 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: 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 Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks. Diabetes Were 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 base pay for this position is $79,500.00 $138,700.00 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: No 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), Keyboard use (greater or equal to 50% of the workday) 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