Quality Systems Analyst

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 115,000 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 family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career of which you dream. 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 high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. 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. Our location in Temecula, CA currently has an opportunity for a Quality Analyst. The Opportunity This position works out of our Temecula, CA location in the Abbott Vascular Division. 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 fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. MAIN RESPONSIBILITIES • Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits). • 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. • Responsible for independently updating audit data and metrics in a timely manner and in accordance with business standards. • Serve as a recognized technical expert in use of Audit Tracking tools. • Maintain, review, and update relevant documents and records to ensure compliance and accuracy. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Collect process data from different parts of the company for analysis and including in reporting of Quality metrics as required. • Exercises authority and judgment within defined limits to determine appropriate action. • Support internal and external team Sharepoint sites. • Assist and support inspection readiness and external audits, as requested. • Works with Regulatory Compliance Management to identify process improvement initiatives within the work area. • Plans, organizes, and prioritizes own daily work routine to meet established schedule. • Cultivates a internal network of resources to facilitate completion of tasks. • Support divisional quality and compliance initiatives, goals, and metrics. • May lead a project team of moderate scope. • Provides guidance to less experienced staff. • Perform other duties and projects as assigned. Minimum Experience / Training Required Education Level Bachelors Degree or an equivalent combination of education and work experience. Masters Degree - Preferred Experience/Background Minimum 2-5+ years Related work experience with a good understanding of specified functional area. Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment. WHAT WE OFFER : At Abbott, you can have a good job that can grow into a great career. We offer: A fast-paced work environment where your safety is our priority Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities 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 and @AbbottGlobal. The base pay for this position is $61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:AVD Vascular LOCATION:United States > Temecula : Building E - TE 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